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Caiger, Anne. "SPEC Kits: Compiled Information about Library Management Policies, Procedures, and Techniques." American Archivist 53, no. 1 (1990): 158–61. http://dx.doi.org/10.17723/aarc.53.1.c32004r2676174l0.
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MYERS, MICHAEL J., HAILE F. YANCY, DOROTHY E. FARRELL, JEWELL D. WASHINGTON, and RUSSELL A. FROBISH. "Evaluation of Two Commercial Lateral-Flow Test Kits for Detection of Animal Proteins in Animal Feed." Journal of Food Protection 68, no. 12 (2005): 2656–64. http://dx.doi.org/10.4315/0362-028x-68.12.2656.
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Performance characteristics were evaluated for two lateral-flow test kits, Reveal for Ruminant in Feed (Neogen Corporation) and FeedChek (Strategic Diagnostics Inc.), designed to detect ruminant or terrestrial animal proteins in feeds. The stringent acceptance criteria used were developed by the Center for Veterinary Medicine Office of Research to identify test kits with comparable selectivity and sensitivity to microscopy and PCR assay, the analytical methods used by the U.S. Food and Drug Administration (FDA). Guidelines were developed for evaluating the selectivity, sensitivity, ruggedness, and spec-ificity of these kits. These guidelines further stated that ruggedness and specificity testing would be performed only after a test passed both the selectivity and sensitivity assessments. Acceptance criteria for determining success were developed using a statistical approach requiring 90% probability of achieving the correct response, within a 95% confidence interval. A minimum detection level of 0.1% bovine meat and bone meal, consistent with the sensitivity of the methods used by the FDA, was required. Selectivity was assessed by testing 60 dairy feed samples that contained no added animal proteins; sensitivity was determined by evaluating 60 samples (per level of fortification) of the same feed that contained 0.025, 0.05, 0.1, 0.25, 0.5, 1, or 2% bovine meat and bone meal. The Reveal test passed the selectivity assessment but failed the sensitivity assessment, detecting only samples fortified at the 2% level and then only 17 to 33% of those samples, when read according to the label directions. The FeedChek test passed the sensitivity assessment but failed the selectivity assessment, with rates for false-positive results ranging from 34 to 38%, depending on the user. The sensitivity of the Reveal test was affected by the concentration of trace minerals present in the feed; concentrations toward the high end of the normal range prevented the detection of true positive feed samples containing bovine meat and bone meal. Better sensitivity assessments were obtained when lamb meal was used either alone or in combination with bovine meat and bone meal. The FeedChek test was not affected by the concentration of trace minerals or by the type of animal meal used. These results indicate that neither of the two tests is adequate for routine regulatory use.
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D'AOUST, J. Y., A. M. SEWELL, and P. GRECO. "Commercial Latex Agglutination Kits for the Detection of Food borne Salmonella." Journal of Food Protection 54, no. 9 (1991): 725–30. http://dx.doi.org/10.4315/0362-028x-54.9.725.
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The ability of the Bactigen® Salmonella Shigella (BSST), the Microscreen® (MS), and the Spectate® (SPECT) latex agglutination kits to detect Salmonella in pure cultures and in naturally contaminated foods was examined. Of 190 Salmonella strains tested, the MS, BSST, and SPECT systems correctly identified 89.5, 81.6, and 66.3% of the test cultures, respectively. The sensitivity of SPECT increased to 92.7% when only strains belonging to the targeted serogroups (somatic A to E plus G) and strains harboring the Vi antigen were considered. The lack of specificity of the MS (3.4%), SPECT (17.0%), and BSST (33.9%) systems with 59 cultures of nonsalmonellae varied widely, with Citrobacter freundii and Escherichia coli accounting for many of the false-positive reactions. Examination of foods according to the prescribed MS and SPECT analytical test protocols identified respectively, 18 (75%) and 19 (79.2%) of the 24 food samples found to contain Salmonella spp. by a standard cultural method. Although instructions with the BSST kit indicate that the product is intended for the analysis of clinical samples, the system nevertheless identified 21 (87.5%) contaminated food samples under homologous MS and SPECT test conditions. The concurrent use of TBG43 with enrichment media recommended by kit manufactures enhanced the sensitivities of MS (83.3%), SPECT (91.7%), and BSST (91.7%). Attempts to effect greater method brevity through the application of latex kits at various stages of the standard cultural procedure were counterproductive.
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Calvert, Philip. "Use of Teams in ARL Libraries20004George J. Soete. Use of Teams in ARL Libraries. Washington, DC.: SPEC Kits No. 232, Association of Research Libraries, Office of Leadership and Management Services 1998. , ISBN: ISSN 01603582 Softback US$40.00 (US$25.00 ARL members)." Library Management 21, no. 5 (2000): 271–78. http://dx.doi.org/10.1108/lm.2000.21.5.271.4.
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Mahmood, Khalid. "Marketing and Public Relations Activities in ARL Libraries20004Evelyn O. Smykla. Marketing and Public Relations Activities in ARL Libraries. Washington DC: Association of Research Libraries, Office of Leadership and Management Services 1999. 109pp., ISBN: 0160 3582 US$40.00 SPEC Kits, 240." Library Review 49, no. 6 (2000): 303–10. http://dx.doi.org/10.1108/lr.2000.49.6.303.4.
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Moore, Penny. "The ARL Geographic Information Systems Literacy Project20011D. Kevin Davie. The ARL Geographic Information Systems Literacy Project. Washington, DC: SPEC Kits 1999. 37 pp. US$40.00 (US$25.00 ARL members) (softback) , ISBN: ISSN 01603582 Association of Research Libraries, Office of Leadership and Management Services." Library Hi Tech 19, no. 1 (2001): 88–89. http://dx.doi.org/10.1108/lht.2001.19.1.88.1.
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Lanier, Don. "The Gifts and Exchange Function in ARL Libraries20001Comp. by Catherine Denning. The Gifts and Exchange Function in ARL Libraries. Washington, DC, Association of Research Libraries, Office of Leadership and Management Services: SPEC Kits, 241 1999. 116 pp., ISBN: 01603582 US$40.00 (US$25.00 ARL members)." Collection Building 19, no. 3 (2000): 126–28. http://dx.doi.org/10.1108/cb.2000.19.3.126.1.
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Osorio, Nestor L. "Library Storage Facilities, Management and Services20011Jan Merrill‐Oldham, Jutta Reed‐Scott. Library Storage Facilities, Management and Services. Association of Research Libraries, Office of Leadership and Management Services, Washington, DC : SPEC Kits, 242 1999. 193 pp., ISBN: ISSN 01603582 $40.00 softcover Edited by Gary Gorman." Collection Building 20, no. 3 (2001): 146–48. http://dx.doi.org/10.1108/cb.2001.20.3.146.1.
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Venzin, Megan. "Apply the KISS Method." Special Events Galore 23, no. 7 (2023): 1. http://dx.doi.org/10.1002/speg.32000.
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Dias, Tarcisio. "Local wh-subjects under Quem nunca? ellipsis." Isogloss. Open Journal of Romance Linguistics 9, no. 4 (2023): 1–20. http://dx.doi.org/10.5565/rev/isogloss.295.
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In this paper I show that there is an elliptical construction in Brazilian Portuguese involving nunca ('never') restricted to locally moved wh-subjects and provide an account of this peculiar restriction. The construction in question corresponds to the sequence Quem nunca? ('Who never?'), which is used as a follow-up comment to a declarative sentence such as Pedro beijou João ('Pedro kissed João'), meaning 'Who did never kiss João?'. Curiously, the wh-element in such cases must correspond to the locally moved subject. I argue that the construction in question provides evidence for Bošković's (2023) proposal regarding two different positions for wh-movement, in which local wh-subjects move to a position below CP and above TP, whereas other wh-elements all move to Spec,CP. I also show this approach provides evidence for the view in which a Spec-head relation is needed for ellipsis licensing.
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Nenn, Kerry. "Keep Kids Entertained at Grown-Up Events." Special Events Galore 16, no. 4 (2016): 1. http://dx.doi.org/10.1002/speg.30298.
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Nenn, Kerry. "Participants Go ‘Over the Edge’ for Kids." Special Events Galore 22, no. 12 (2022): 7. http://dx.doi.org/10.1002/speg.31888.
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Bigi, Nedeleg, Morgann Behrel, Kostia Roncin, et al. "Dynamic modeling of ships towed by kite." La Houille Blanche, no. 1 (February 2018): 8–10. http://dx.doi.org/10.1051/lhb/2018002.
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A dynamic kite flight can affect ship motions. Ship equations of motion associated with the analytical zero-mass kite model are developed. Aiming a realistic amplitude modeling of the kite excitation, a linear modification of the aerodynamic kite specs with the turning rate of the kite velocity heading is proposed. A good agreement with experimental data is obtained. Equations of motion are solved on a reaching path alternatively with a weak and a strong coupling between the ship and the kite. Differences between the two coupling methods become significant when a harmonic of the kite excitation approaches the natural roll frequency of the ship. For the presented case of study, these critical conditions can be avoided with longer tethers or larger kite trajectories.
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Nenn, Kerry. "Breakfast Allows Kids to Dress As Their Favorite Characters." Special Events Galore 23, no. 2 (2023): 3. http://dx.doi.org/10.1002/speg.31914.
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Nenn, Kerry. "‘Kids Diggin’ for a Cause' Gives Youngsters an Immersive Experience." Special Events Galore 24, no. 2 (2024): 5. http://dx.doi.org/10.1002/speg.32115.
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Sokołowski, Łukasz. "Serial jako element praktyk społecznych." Kultura i Społeczeństwo 55, no. 2-3 (2011): 187–208. http://dx.doi.org/10.35757/kis.2011.55.2-3.10.
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The purpose of the article is to show how the TV-series — one of the most importantforms of television production — is incorporated into the daily routines of the spec-tators. Michel de Certeau perspective of applied sociology of everyday life and criticalreflection on everyday life is used as a theoretical framework. In the case of TV-series,the routines can take a form of: (1) “logging in” and “reading”” TV-series, (2) movementand sociability routines, and (3) discursive development of received meanings. “Soapopera experience” consists mainly of linguistic practices cultivated while watching theseries, which is a modern form of storytelling, socializing, which changes the audiences’view of reality, its social framework for evaluation and interpretation. A viewer is crit-ical and active; they use consumption processes as an excuse to construct their ownmeanings and narratives, and negotiate the meaning of what is presented to them.
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Ignacio, Aris E., and Mark Angelo A. Ligot. "EmbrASD: Android Mobile Application for Children with Autism as a Supplemental Tool for Therapy." Indonesian Journal of Engineering Research 2, no. 2 (2021): 61–67. http://dx.doi.org/10.11594/10.11594/ijer.02.02.05.
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Autism has a very wide range that influences people, specifically children in general. Usually, it affects a child’s social interaction, communication, behaviors, and interests. Providing a complete device for treatment which is planned to be used by kids with autism needs to be taken into consideration. There is no software available that will adhere to the main areas of autism. The development a multidimensional software that focuses the main areas of kids with autism was a specific goal that the paper is being addressed. It is planned from the viewpoint of several specialists: more particularly speech therapist, occupational therapist, Special Education (SPED) educator and an Applied Behavior Analysis (ABA) specialist. The specialists’ focused objectives were lengthily included into the planning of the software. The development of an application for the young with autism that would completely attend to all the main areas that are initiated by autism and serves as an addendum to treatment is the primary goal of the study. Interviews from, speech therapist, occupational therapist, SPED teacher, ABA therapist and a SPED therapist will serve as a basis and the prototyping methodology for system development. With the implemented system, the intended users gave an approval on the application to be integrated in the teaching of children with autism. Suggestions on the improvement of the application comprises of including video recording for API 22, implementing the system in the iOS environment, and concentration on older autism cases were recommended.
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Ghoreishi, Seyedeh Masoumeh, Atena Najdian, Sina Yadegari, et al. "The Use of Carbon Quantum Dot as Alternative of Stannous Chloride Application in Radiopharmaceutical Kits." Contrast Media & Molecular Imaging 2020 (November 6, 2020): 1–11. http://dx.doi.org/10.1155/2020/4742158.
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Even today, technetium-99m is a radionuclide choice for diagnostic in nuclear medicine. The unique chemical and physical properties of technetium-99m make it suitable as an available radionuclide in many centers. In this study, we examined the potential of CQD as a reducing agent in the MDP kit. Citric acid-derived CQD was synthesized and confirmed by FT-IR, TEM, UV-Vis, XPS, and surface analysis. No cytotoxicity was observed by the MTT assay. They were reducing properties of the CQD confirmed by fluorescence microscopy. The MDP kit is prepared by evaluating different parameters that affect the radiolabeling yield, including ligand, time, and CQD. The optimum amount of each parameter is obtained by Box–Behnken software. Finally, fluorescent spectroscopy, SPECT imaging, and biodistribution study showed that CQD reduces technetium-99m. Accumulation of radiotracer in the femur showed that CQD could be used in a radiopharmaceutical kit.
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Abu Owida, Hamza, Hassan S. Migdadi, Omar Salah Mohamed Hemied, Nawaf Farhan Fankur Alshdaifat, Suhaila Farhan Ahmad Abuowaida, and Rami S. Alkhawaldeh. "Deep learning algorithms to improve COVID-19 classification based on CT images." Bulletin of Electrical Engineering and Informatics 11, no. 5 (2022): 2876–85. http://dx.doi.org/10.11591/eei.v11i5.3802.
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In response to the growing threat posed by COVID-19, several initiatives have been launched to develop methods of halting the progression of the disease. In order to diagnose the COVID-19 infection, testing kits were utilized; however, the use of these kits is time-consuming and suffers from a lack of quality control measures. Computed tomography is an essential part of the diagnostic process in the treatment of COVID-19 (CT). The process of disease detection and diagnosis could be sped up with the help of automation, which would cut down on the number of exams that need to be carried out. A number of recently developed deep learning tools make it possible to automate the Covid-19 scanning process in CT scans and provide additional assistance. This paper investigates how to quickly identify COVID-19 using computational tomography (CT) scans, and it does so by using a deep learning technique that is derived from improving ResNet architecture. In order to test the proposed model, COVID-19 CT scans that include a patient-based split are utilized. The accuracy of the model’s core components is 98.1%, with specificity at 97% and sensitivity at 98.6%.
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De Martin, Benedito Wlademir, Teresinha Moraes Barreto Rockman, José Muradian, et al. "Avaliação experimental de "spect" cerebral mediante utilização do d,1 - HMPAO 99mTc em cães. Considerações anátomo-fisiológicas." Brazilian Journal of Veterinary Research and Animal Science 32, no. 1 (1995): 1. http://dx.doi.org/10.11606/issn.1678-4456.bjvras.1994.52081.
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O d,1 - Hexametilpropileno oxima marcado com o tecnécio-99m(99mTc-HMPAO) é um importante radiofármaco usado tanto para imagens tomográficas cerebrais quanto na marcação “in vitro" de leucócitos. A crescente utilização deste radiofármaco no estudo de doenças neurológicas no homem levou-nos à obtenção de "kits" de HMPAO para ser marcado pelo tecnécio-99m. Neste trabalho apresentamos o estudo experimental efetuado com "kits" liofilizados de d,1 – HMPAO99mTc desenvolvidos em nossos laboratórios, comparando inclusive com aqueles encontrados no comércio. As imagens cerebrais inicialmente foram feitas em coelhos, entretanto os melhores resultados foram obtidos em cães. Assim, selecionaram-se seis cães sem raça definida, considerados clinicamente normais para obtenção das imagens cintilográficas do cérebro e o “washout” das regiões de interesse (ROls). Os estudos experimentais em animais e a considerável redução do custo do radiofármaco mostrou-nos a possibilidade da utilização destes exames na clínica veterinária, especialmente de pequenos animais. Por outro lado, a perfusão do d,l – HMPAO99mTc mostra que a concentração do radiofármaco se faz ao mesmo tempo na região do cérebro e nas fossas nasais, demonstrando a existência de estruturas iguais às da barreira hemo-encefálica nesta última região.
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Abouzayed, Ayman, Jesper Borin, Fanny Lundmark, et al. "The GRPR Antagonist [99mTc]Tc-maSSS-PEG2-RM26 towards Phase I Clinical Trial: Kit Preparation, Characterization and Toxicity." Diagnostics 13, no. 9 (2023): 1611. http://dx.doi.org/10.3390/diagnostics13091611.
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Gastrin-releasing peptide receptors (GRPRs) are overexpressed in the majority of primary prostate tumors and in prostatic lymph node and bone metastases. Several GRPR antagonists were developed for SPECT and PET imaging of prostate cancer. We previously reported a preclinical evaluation of the GRPR antagonist [99mTc]Tc-maSSS-PEG2-RM26 (based on [D-Phe6, Sta13, Leu14-NH2]BBN(6-14)) which bound to GRPR with high affinity and had a favorable biodistribution profile in tumor-bearing animal models. In this study, we aimed to prepare and test kits for prospective use in an early-phase clinical study. The kits were prepared to allow for a one-pot single-step radiolabeling with technetium-99m pertechnetate. The kit vials were tested for sterility and labeling efficacy. The radiolabeled by using the kit GRPR antagonist was evaluated in vitro for binding specificity to GRPR on PC-3 cells (GRPR-positive). In vivo, the toxicity of the kit constituents was evaluated in rats. The labeling efficacy of the kits stored at 4 °C was monitored for 18 months. The biological properties of [99mTc]Tc-maSSS-PEG2-RM26, which were obtained after this period, were examined both in vitro and in vivo. The one-pot (gluconic acid, ethylenediaminetetraacetic acid, stannous chloride, and maSSS-PEG2-RM26) single-step radiolabeling with technetium-99m was successful with high radiochemical yields (>97%) and high molar activities (16–24 MBq/nmol). The radiolabeled peptide maintained its binding properties to GRPR. The kit constituents were sterile and non-toxic when tested in living subjects. In conclusion, the prepared kit is considered safe in animal models and can be further evaluated for use in clinics.
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Jeong, Seongkwon, and Jaejin Lee. "Iterative LDPC-SPC Product Code with LLR Controller for Bit-Patterned Media Recording." Journal of Korean Institute of Communications and Information Sciences 45, no. 2 (2020): 239–44. http://dx.doi.org/10.7840/kics.2020.45.2.239.
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Sheehan, Michelle. "Extraposition and antisymmetry." Linguistic Variation Yearbook 2010 10 (December 31, 2010): 201–51. http://dx.doi.org/10.1075/livy.10.06she.
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‘Extraposition’ is a cover term for two distinct phenomena (cf. also Fox & Nissenbaum 1999; Kiss 2005). The first, which I assume to be derived by parallel construal (following Koster 2000), targets only RCs, blocks reconstruction of the extraposed constituent to the base position of the source, and as such has the effect of bleeding condition C. The second, which I claim is derived via scattered deletion, targets post-head complements/modifiers, triggers obligatory reconstruction of the source+complement/modifier to base-position and leaves extraposed complements open to subextraction, all else being equal. The scattered deletion of spec+head and complement is argued to be derived from Uriagereka's (1999) simplification of the LCA, and the copy theory of labelling (cf. Sheehan 2010). Keywords: linearisation; extraposition; multiple spell-out; LCA; labelling; reconstruction; relative clause; complement PP; scattered deletion
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Singh, Dr Jagjeet. "ISSUES AND CHALLENGES IN SPECIAL EDUCATION: A QUALITATIVE ANALYSIS FROM TEACHER’S PERSPECTIVE." Global International Research Thoughts 11, no. 1 (2023): 6–10. http://dx.doi.org/10.36676/girt.2023-v11i1-02.
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The primary goal of this study is to better understand the challenges that special education (SPED) teachers in the City Division of Ilagan Isabela, Philippines experience when trying to help students who have difficulty learning new content. Purposive sampling was used to identify the 15 special education teachers who agreed to take part in the study as respondents. Educator challenges were identified by use of the Qualitative Research Method (QRM). The data was analysed using a thematic approach. Five distinct themes emerged from the analyses of the key informants' collective descriptions of the difficulties they face in their roles as SPED teachers: selecting an appropriate strategy and motivation; identifying individual needs; finding the job challenging but fulfilling; accepting and having patience with students; and respecting students' rights. The majority of teachers who assist students with learning disabilities have never taken a course on special needs education. Since this is the case, they feel unprepared to teach students with learning impairments. Furthermore, teachers who are given the task of instructing children in SPED classrooms often lack the strategies essential for working with kids who have impairments. The study concluded that the Division of Ilagan's special education classes as a whole lack the resources necessary to implement Specialized Programs for the Education of Disabled Children (SPED), including adequate funding, a standardised curriculum, instructional materials, and physical space.
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YAVUZ, Hatice Sümeyye, Müge ÖNER TAMAM, Halim OZCEVİK, Ahmet YAVUZ, and Mehmet MÜLAZIMOĞLU. "Evaluation of Tc-99m Labeled Erythrocyte Scintigraphy with SPECT/CT in the Diagnosis of Hepatic Hemangioma." İstanbul Gelişim Üniversitesi Sağlık Bilimleri Dergisi, no. 19 (April 29, 2023): 98–109. http://dx.doi.org/10.38079/igusabder.1035135.
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Amaç: Günümüzde görüntüleme yöntemlerindeki gelişmeyle birlikte karaciğer hemanjiomlarının saptanması da artmıştır. Genellikle asemptomatik olan karaciğer hemanjiomlarının, karaciğerin diğer primer ve metastatik malign tümörlerinden ayırıcı tanısının konulması gerekmektedir. Özellikle boyutu küçük olan ve ana vasküler yapılara yakın olan lezyonların tanısını koymak önemlidir. Bu tip lezyonlar Tc-99m işaretli eritrosit sintigrafisi ile doğru olarak tanımlanabilir. Bu çalışmanın amacı karaciğer hemanjiomlarının Tc-99m işaretli eritrosit sintigrafisinin SPECT/BT ile değerlendirilmesi ve tanıya olan katkısını araştırmaktır. Yöntem: Hemanjiom ön tanısı ile kliniğimize gönderilen 36 olgudaki 40 lezyon retrospektif olarak değerlendirildi. Modifiye in vivo yöntemle Tc-99m işaretli eritrosit sintigrafisi yapılan 36 hasta SPECT/BT ile görüntülendi. Hastalar 12-24 aylık klinik bulgu ve diğer görüntüleme yöntemleri (USG, BT ve MRG) ile takip edildi. Yapılan takiplerle lezyonların boyut ve morfolojisinde değişiklikler değerlendirilerek tanıları doğrulandı. Bulgular: SPECT/BT ile görüntülemede 36 olgunun 29’unda aktivite artışı saptandı ve bu olguların hepsi gerçek pozitif olarak değerlendirildi. 7 olguda aktivite tutulumu olmadı. 2 olgu kist hidatik, 4 olgu metastaz (1 kolon kanseri, 3 meme kanseri) olarak belirlendi. 1 olgu ise yanlış negatif olarak saptandı. Bu olguda lezyon boyutu 1 cm idi. Tc-99m işaretli eritrosit sintigrafisi-SPECT/BT ile sensitivite:%100; spesifite: %96,7; pozitif prediktif değer: %100; negatif prediktif değer: % 85,7 ve toplam tanı değeri: %97,3 olarak belirlendi. Ayrıca SPECT/BT’de 9 (%25) olguda lezyonlar ana vasküler yapılara yakın yerleşimli idi. Lezyonların 1’i kalbe, 3’ü vena kava inferiora, 5’i ise büyük hepatik damarlara yakın yerleşimli idi. BT sayesinde radyoaktivite akümülasyonunun olduğu odağın doğru anatomik lokalizasyonu yapılarak hastalara hemanjiom tanısı kondu. Sonuç: Tc-99m işaretli eritrosit sintigrafisi SPECT/BT sayesinde karaciğer hemanjiomlarının tespitinde sensitivitesi, spesifitesi ve doğruluğu yüksek olan, fonksiyonel ve anatomik görüntülemenin bir arada yapılmasına sağlayan noninvaziv bir görüntüleme yöntemidir.
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Vallejo-Armenta, Paola, Clara Santos-Cuevas, Juan Soto-Andonaegui, et al. "99mTc-CXCR4-L for Imaging of the Chemokine-4 Receptor Associated with Brain Tumor Invasiveness: Biokinetics, Radiation Dosimetry, and Proof of Concept in Humans." Contrast Media & Molecular Imaging 2020 (April 27, 2020): 1–10. http://dx.doi.org/10.1155/2020/2525037.
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Overexpression of the chemokine-4 receptor (CXCR4) in brain tumors is associated with high cancer cell invasiveness. Recently, we reported the preclinical evaluation of 99mTc-CXCR4-L (cyclo-D-Tyr-D-[NMe]Orn[EDDA-99mTc-6-hydrazinylnicotinyl]-Arg-NaI-Gly) as a SPECT radioligand capable of specifically detecting the CXCR4 protein. This research aimed to estimate the biokinetic behavior and radiation dosimetry of 99mTc-CXCR4-L in healthy subjects, as well as to correlate the radiotracer uptake by brain tumors in patients, with the histological grade of differentiation and CXCR4 expression evaluated by immunohistochemistry. 99mTc-CXCR4-L was obtained from freeze-dried kits prepared under GMP conditions (radiochemical purities >97%). Whole-body scans from six healthy volunteers were acquired at 0.3, 1, 2, 4, 6, and 24 h after 99mTc-CXCR4-L administration (0.37 GBq). Time-activity curves of different source organs were obtained from the image sequence to adjust the biokinetic models. The OLINDA/EXM code was employed to calculate the equivalent and effective radiation doses. Nine patients with evidence of brain tumor injury (6 primaries and 3 recurrent), determined by MRI, underwent cerebral SPECT at 3 h after administration of 99mTc-CXCR4-L (0.74 GBq). Data were expressed as a T/B (tumor uptake/background) ratio. Biopsy examinations included histological grading and anti-CXCR4 immunohistochemistry. Results showed a fast blood activity clearance (T1/2α = 0.81 min and T1/2β = 12.19 min) with renal and hepatobiliary elimination. The average equivalent doses were 6.10E − 04, 1.41E − 04, and 3.13E − 05 mSv/MBq for the intestine, liver, and kidney, respectively. The effective dose was 3.92E − 03 mSv/MBq. SPECT was positive in 7/9 patients diagnosed as grade II oligodendroglioma (two patients), grade IV glioblastoma (two patients), grade IV gliosarcoma (one patient), metastasis, and diffuse astrocytoma with T/B ratios of 1.3, 2.3, 13, 7, 19, 5.5, and 3.9, respectively, all of them with positive immunohistochemistry. A direct relationship between the grade of differentiation and the expression of CXCR4 was found. The two negative SPECT studies showed negative immunohistochemistry with a diagnosis of reactive gliosis. This “proof-of-concept” research warrants further clinical studies to establish the usefulness of 99mTc-CXCR4-L in the diagnosis and prognosis of brain tumors.
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Villareal, Sheila J., Francisco P. Panopio Jr, Consortia S. Tan, Marcial M. Bandoy, and Lerma P. Buenvinida. "A Phenomenological Studies of Special Education Teachers and Parents Lived Experiences In Upholding Learners With Disability (Lwd) In Transition Program During Pandemic." International Journal of Theory and Application in Elementary and Secondary School Education 4, no. 2 (2022): 219–34. http://dx.doi.org/10.31098/ijtaese.v4i2.1116.
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The implementation of a transition program for special education students is hardcore during face-to-face and it became more difficult to implement during distance education. The research aimed to explore the essence of the experiences of Special Education (SPED) teachers and parents under the transition curriculum. This study utilized qualitative design. Particularly, this study employed a phenomenological research design. The participants of this study were eight (8) parents having LWD at home enrolled in the school SY 2021-2022 under Special Education Program and five (5) SPED teachers. The information and replies of the participants were gathered using a semi-structured interview guide. Coding and triangulation were done to analyze and identify the emerging theme. The emerging themes for the teachers lived experiences revealed flexibility and adaptability in times of pandemic, the power of communication, and effective problem-solving strategies. For the parents, the main themes that emerged from their testimonies were the needs for assistance and parent as a manager. The findings also revealed that all problems related to the transition curriculum were addressed and solved by teachers and parents by working with each other. Knowing how parents struggles due to their work and parental roles helped the teachers to understand them and help them build a strong relationship based on trust and understanding. The researcher recommended that the school may intensify the relationship between the teachers and parents by improving communication, collaboration, and cooperation between them. To help the parents more in assisting their kids, parenting techniques, mentoring, and coaching programs may be provided.
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Thakur, Riptee, Chandana Nagaraj, Raman Kumar Joshi, Jitender Saini, Ravi Yadav, and Pardeep Kumar. "Standardization and Clinical Use of a Single-vial Formulation of Technetium-99m-Trodat Using Autoclave Method." Indian Journal of Nuclear Medicine 39, no. 1 (2024): 18–23. http://dx.doi.org/10.4103/ijnm.ijnm_104_23.
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Background: Parkinson’s disease (PD) is characterized by the degeneration of dopaminergic neurons in the substantia nigra. SPECT imaging using technetium-99m [99mTc] labeled trodat is the choice of imaging to differentiate PD from its other forms like drug-induced PD. Aims and Objectives: The main objective of our study was to prepare in-house sterile formulation of [99mTc]Tc-trodat and use in clinics. Materials and Methods: The labeling of trodat was standardized using glucoheptonate sodium salt (GHA), stannous chloride dihydrate (in 0.05 N HCl), and ethylenediaminetetraacetic acid (Na-EDTA). The preparation was mixed and autoclaved at 15 psi for 15 min. The standardised formulation was stored at 4°C, -20°C and -80°C and labeling with 99mTc was tested for up to 6 days. The radiochemical purity, chemical impurities, and endotoxin levels were tested. The frozen formulation was tested in swiss mice (n = 3) for biodistribution studies at 4 h. Around 18 ± 2 mCi was injected intravenously in each patient (n = 5) and the image was acquired at 4 h post-injection. Results: The radiochemical purity of the preparation was 98.3 ± 1.4% with a retention time of 16.8 ± 1.5 min as compared to 4.0 ± 0.5 min for free 99mTc. Animal distribution showed highest uptake in liver and dual excretion via hepatobiliary and renal system. [99mTc]Tc-trodat imaging was able to differentiate both caudate and putamen. Conclusions: In-house frozen preparation was advantageous, as it has decreased the chance of manual error as compared to daily make up formulations and economical as compared to commercially available kits.
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Vallejo-Armenta, Paola, Guillermina Ferro-Flores, Clara Santos-Cuevas, et al. "[99mTc]Tc-iFAP/SPECT Tumor Stroma Imaging: Acquisition and Analysis of Clinical Images in Six Different Cancer Entities." Pharmaceuticals 15, no. 6 (2022): 729. http://dx.doi.org/10.3390/ph15060729.
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Fibroblast activation protein (FAP) is highly expressed on the cancer-associated fibroblasts (CAF) of the tumor stroma. Recently, we reported the preclinical evaluation and clinical biokinetics of a novel 99mTc-labeled FAP inhibitor radioligand ([99mTc]Tc-iFAP). This research aimed to evaluate [99mTc]Tc-iFAP for the tumor stroma imaging of six different cancerous entities and analyze them from the perspective of stromal heterogeneity. [99mTc]Tc-iFAP was prepared from freeze-dried kits with a radiochemical purity of 98 ± 1%. The study included thirty-two patients diagnosed with glioma (n = 5); adrenal cortex neuroendocrine tumor (n = 1); and breast (n = 21), lung (n = 2), colorectal (n = 1) and cervical (n = 3) cancer. Patients with glioma had been evaluated with a previous cranial MRI scan and the rest of the patients had been involved in a [18F]FDG PET/CT study. All oncological diagnoses were corroborated histopathologically. The patients underwent SPECT/CT brain imaging (glioma) or thoracoabdominal imaging 1 h after [99mTc]Tc-iFAP administration (i.v., 735 ± 63 MBq). The total lesions (n = 111) were divided into three categories: primary tumors (PT), lymph node metastases (LNm), and distant metastases (Dm). [99mTc]Tc-iFAP brain imaging was positive in four high-grade WHO III–IV gliomas and negative in one treatment-naive low-grade glioma. Both [99mTc]Tc-iFAP and [18F]FDG detected 26 (100%) PT, although the number of positive LNm and Dm was significantly higher with [18F]FDG [82 (96%)], in comparison to [99mTc]Tc-iFAP imaging (35 (41%)). Peritoneal carcinomatosis lesions in a patient with recurrent colorectal cancer were only visualized with [99mTc]Tc-iFAP. In patients with breast cancer, a significant positive correlation was demonstrated among [99mTc]Tc-iFAP uptake values (Bq/cm3) of PT and the molecular subtype, being higher for subtypes HER2+ and Luminal B HER2-enriched. Four different CAF subpopulations have previously been described for LNm of breast cancer (from CAF-S1 to CAF-S4). The only subpopulation that expresses FAP is CAF-S1, which is preferentially detected in aggressive subtypes (HER2 and triple-negative), confirming that FAP+ is a marker for poor disease prognosis. The results of this pilot clinical research show that [99mTc]Tc-iFAP SPECT imaging is a promising tool in the prognostic assessment of some solid tumors, particularly breast cancer.
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Thakkar, Prashant V., Katsuhiro Kita, Urko del Castillo, et al. "Abstract 2623: Variants of CLIP-170 associated with taxane resistance in tumors." Cancer Research 82, no. 12_Supplement (2022): 2623. http://dx.doi.org/10.1158/1538-7445.am2022-2623.
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Abstract Despite its widespread use, the majority of patients with gastric cancer (GC) will not respond to taxane chemotherapy due to resistance mechanisms. Recently, we reported the discovery of a novel truncated variant of the microtubule plus-end binding protein CLIP-170, hereafter CLIP-170S, whose expression is enriched in taxane resistant cell lines and patients with GC. Mass-spec proteomics and 5’-RACE further showed that CLIP-170S lacked the first 155 amino acids, including the Cap-Gly motif required for microtubule plus-end localization. CLIP-170S knockdown reversed taxane resistance in cells and xenografts, whereas its re-expression led to resistance, suggesting causation. Unlike canonical CLIP-170, we showed that CLIP-170S was mislocalized from the MT plus-end to the MT lattice. Computational analysis of RNA-seq data in conjunction with the connectivity map from taxane-sensitive and resistant GC cell lines, predicted imatinib as the top candidate drug to overcome drug resistance. Imatinib treatment completely reversed taxane resistance, as predicted, and did so unexpectedly by selective depletion of CLIP-170S. Other RTK inhibitors also depleted CLIP-170S, suggesting a class effect. We are currently unraveling the molecular mechanisms by which a) CLIP-170S impairs taxane association to its microtubule binding site and b) Imatinib and other RTK inhibitors selectively deplete CLIP-170S. Our data show that CLIP-170S is a clinically prevalent variant that confers taxane resistance in tumors, whereas the discovery of Imatinib as a CLIP-170S inhibitor provides novel therapeutic opportunities for future trials. Citation Format: Prashant V. Thakkar, Katsuhiro Kita, Urko del Castillo, William G. Stone, Giuseppe Galletti, Neel Madhukar, Elena Vila Navarro, Elena Barasoain, Holly V. Goodson, Dan Sackett, José Fernando Díaz, Yao Lu, Arindam RoyChoudhury, Henrik Molina, Olivier Elemento, Manish A. Shah, Paraskevi Giannakakou. Variants of CLIP-170 associated with taxane resistance in tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 2623.
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Tamura, Naohisa, Erika Watanabe, Rumi Shirakawa, et al. "Comparisons of plasma aldosterone and renin data between an automated chemiluminescent immunoanalyzer and conventional radioimmunoassays in the screening and diagnosis of primary aldosteronism." PLOS ONE 16, no. 7 (2021): e0253807. http://dx.doi.org/10.1371/journal.pone.0253807.
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Determining values of plasma renin activity (PRA) or plasma active renin concentration (ARC), plasma aldosterone concentration (PAC), and aldosterone-to-renin ratio (ARR) is essential to diagnose primary aldosteronism (PA), but it takes several days with conventional radioimmunoassays (RIAs). Chemiluminescent enzyme immunoassays for PAC and ARC using the Accuraseed® immunoanalyzer facilitated the determination, but relations between Accuraseed® immunoanalyzer-based and RIA-based values in samples of PA confirmatory tests and adrenal venous sampling remained to be elucidated. We addressed this issue in the present study. This is a prospective, cross-sectional study. ARC and PAC values were measured by the Accuraseed® immunoanalyzer in samples, in which PRA and PAC values had been measured by the PRA-FR® RIA and SPAC®-S Aldosterone kits, respectively. The relations between Accuraseed® immunoanalyzer-based and RIA-based values were investigated with regression analyses. The optimal cutoff of Accuraseed® immunoanalyzer-based ARR for PA screening was determined by the receiver operating characteristic analysis. After log-log transformations, linear relations with high coefficients of determination were observed between Accuraseed® immunoanalyzer-based and RIA-based data of renin and aldosterone. Following the PA guidelines of Japan Endocrine Society, Accuraseed® immunoanalyzer-based cutoffs were calculated from the regression equations: the basal PAC for PA screening >12 ng/dL, PAC for the saline infusion test >8.2 ng/dL, ARC for the furosemide-upright test <15 pg/mL, and ARR for the captopril challenge test >3.09 ng/dL per pg/mL. The optimal cutoff of Accuraseed® immunoanalyzer-based ARR for PA screening was >2.43 ng/dL over pg/mL not to overlook bilateral PA patients. The present study provided conversion formulas between Accuraseed® immunoanalyzer-based and RIA-based values of renin, aldosterone, and ARR, not only in basal samples but also in samples of PA confirmatory tests and adrenal venous sampling. Although validation studies are awaited, the present study will become priming water of harmonization of renin and aldosterone immunoassays.
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Nolasco, Marita Nimiah P. "SPED Teachers’ Extent of Implementing Picture Exchange Communication System: It’s Effect on the Functional Communication Skills of Learners with Down Syndrome." International Journal of Multidisciplinary: Applied Business and Education Research 3, no. 9 (2022): 1812–20. http://dx.doi.org/10.11594/ijmaber.03.09.21.
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People with limited or no communication skills can use the Picture Exchange Communication System, or PECS, to communicate visually. Based on an evaluation of the functional communication skills of students with Down syndrome, this study investigated the profile of the respondents, the respondents' level of implementation of the Picture Exchange Communication System for students with Down Syndrome, the level of effectiveness of using the Picture Exchange Communication System, and the connection between these variables. The descriptive correlational research method was used for the study. The study's respondents were special education teachers from various schools in NCR. The study's respondents were chosen through the use of purposeful sampling. Frequency count, percentage, mean, weighted mean, and the chi-square test were used to tabulate and evaluate the data collected. The respondents are aged 38 on average, with more females than males. The majority of the instructors has bachelor's degrees in early childhood special education. Additionally, it was discovered that these teachers had been working in the field for an average of 7 years. The picture exchange communication system for kids with down syndrome is being used by these teachers to a very high degree, according to the research on its deployment. Based on the evaluation of the functional communication abilities of students with down syndrome, the picture exchange communication system (PECS) is rated as fair or emerging in terms of its effectiveness. Significant relationship was also observed between age and the level of effectiveness, Gender and extent of implementation.
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Liu, Zhen-huan, Yan-chao Qi, Pei-guang Pan, et al. "Clinical observation on effect of clearing the governor vessel and refreshing the mind needling on head SPECT and CT scanning of kids with cerebral palsy." Journal of Acupuncture and Tuina Science 5, no. 4 (2007): 209–12. http://dx.doi.org/10.1007/s11726-007-0210-6.
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Mudawi, Naif Al, Mahwish Pervaiz, Bayan Ibrahimm Alabduallah, et al. "Predictive Analytics for Sustainable E-Learning: Tracking Student Behaviors." Sustainability 15, no. 20 (2023): 14780. http://dx.doi.org/10.3390/su152014780.
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The COVID-19 pandemic has sped up the acceptance of online education as a substitute for conventional classroom instruction. E-Learning emerged as an instant solution to avoid academic loss for students. As a result, educators and academics are becoming more and more interested in comprehending how students behave in e-learning settings. Behavior analysis of students in an e-learning environment can provide vision and influential factors that can improve learning outcomes and guide the creation of efficient interventions. The main objective of this work is to provide a system that analyzes the behavior and actions of students during e-learning which can help instructors to identify and track student attention levels so that they can design their content accordingly. This study has presented a fresh method for examining student behavior. Viola–Jones was used to recognize the student using the object’s movement factor, and a region-shrinking technique was used to isolate occluded items. Each object has been checked by a human using a template-matching approach, and for each object that has been confirmed, features are computed at the skeleton and silhouette levels. A genetic algorithm was used to categorize the behavior. Using this system, instructors can spot kids who might be failing or uninterested in learning and offer them specific interventions to enhance their learning environment. The average attained accuracy for the MED and Edu-Net datasets are 90.5% and 85.7%, respectively. These results are more accurate when compared to other methods currently in use.
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Elbadawi Hussien, Mohamed Elmekki Ali. "Bird Electrocution and Collisions with Power Infrastructure in Elgazeira, Kassala and Gadarif States, Sudan." Open Access Journal of Veterinary Science & Research 3, no. 4 (2018): 1–8. http://dx.doi.org/10.23880/oajvsr-16000166.
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This study was conduct ed at Elgazeira, kassala and Gadarif states, covered two seasons in exception of Gadarif state studied in the last season only. The first season from 28/6/2015 to 6/7/2015, and another season from 24 December 2015 - 6 January 2016, to assess the bird's mort ality caused by the power lines . Objectives of this study are: Describe types of killer power lines, and determine numbers of bird species, that are killed by collisions or electrocutions. There were 43 lines traversed in the study area, as follow: 20 line s in the Gaziera state, 9 lines in Gadarif and 14 in kassala. Line transects was adopted to cover the targeted lines. Types of these lines that used were 11 Kilo volte, 33 kilo volte, and 66 kilo volte. Lines were intensive studied by four members under an d at the both sides of the line to cover about twenty meters at each side. Dead birds found at an area of 20 meters beneath the line recorded by location using GPS, then classified and documented by digital camera, a photo taken for the poles with its surr ound habitat. Electrocuted birds distinguished by the signs like burning, injures or the location of the birds from the pole. Dead birds after been registered collected to avoid replication. Number of dead birds was 357 individuals classified into 23 spec ies most are member of the order Falconiformes which comprised a total of 257 individuals, about 72 % of the whole percentage. The proportion of Ciconiiformes was 64 individuals of 18%. Less proportion was Passeriformes and Charadriiformes. Electrocuted bir ds were 301 individuals 84.3% higher than collition 56 birds 15.7%. It should be noticed that birds of prey were more affected by power lines mainly at Kassala state, Lesser kestrel 20.7%, Black kite 16.3% Common kestrel 15.1% while Pied crow suffere d more in Gaziera state 31 individuals of 8.7%. The total number of birds not reflects the exact real because there are many factors such as Scavengers and carnivores or removing by ploughing or humans.
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Ezeana, Chika F., Tiancheng He, Tejal A. Patel, et al. "Abstract 5698: A multicenter study validated an integrated deep learning model for precision malignancy risk assessment and reducing unnecessary biopsies in BI-RADS 4 cases." Cancer Research 83, no. 7_Supplement (2023): 5698. http://dx.doi.org/10.1158/1538-7445.am2023-5698.
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Abstract Introduction: BI-RADS category 4 is associated with a wide variability in probability of malignancy, ranging from 2 to 95% while biopsy-derived positive predictive value (PPV3) for this category’s lesions remains low at 21.1% in the US. A major fallout of these facts is that we have way very high false positive rate leading to too many unnecessary biopsies and their associated costs and emotional burden. We improved our in-house intelligent-augmented Breast cancer RISK calculator (iBRISK), an integrated deep learning (DL) based decision support app and assessed its performance in a multicenter IRB-approved study. Methods: We improved iBRISK by retraining the DL model with an expanded dataset of 9,700 patient records of clinical risk-factors and mammographic descriptors from Houston Methodist Hospital (HMH) and validated using another 1,078 patient records. These patients were all seen between March 2006 and December 2016. We assessed the model using blinded, independent retrospective BI-RADS 4 patients who had biopsies subsequently after mammography and seen January 2015 - June 2019 at three major healthcare institutions in Texas, USA: MD Anderson Cancer Center, the University of Texas Health Sciences Center at San Antonio, and HMH. We dichotomized and trichotomized the data to evaluate precision of risk stratification and probability of malignancy (POM) estimation translated into biopsy decision augmentation. The iBRISK score as a continuous predictor of malignancy and possible cost savings was also analyzed. Results: The multicenter validation dataset had 4,209 women, median age (interquartile) was 56 (45, 65) years. The use of iBRISK score as a continuous predictor of malignancy yielded an AUC of 0.97. Among “low” and “moderate” POM patients, only two out of 1,228 patients (0.16%) and 118 out of 1788 (6.6%) were malignant respectively. This translates to an even better precision when compared to newly introduced BI-RADS 4 subcategories 4A and 4B, with associated PPV3s of 7.6% and 22%, respectively. The “high” POM group had a malignancy rate of 85.9% (1,025/1,193). Estimated potential cost savings in the US was over $260 million. Conclusion: The iBRISK app demonstrated high sensitivity in malignancy prediction and can potentially be used to safely obviate biopsies in up to 50% of patients in low/moderate POM-groups. This would result in significant healthcare quality improvement, cost savings, and help reduce patient anxiety. Citation Format: Chika F. Ezeana, Tiancheng He, Tejal A. Patel, Virginia Kaklamani, Maryam Elmi, Erica Ibarra, Pamela M. Otto, Kenneth A. Kist, Heather Speck, Lin Wang, Joe Ensor, Ya-Chen T. Shih, Bumyang Kim, I-Wen Pan, David Spak, Wei T. Yang, Jenny C. Chang, Stephen T. Wong. A multicenter study validated an integrated deep learning model for precision malignancy risk assessment and reducing unnecessary biopsies in BI-RADS 4 cases. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5698.
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Nandakumar, Bharat, David L. Murray, Angela Dispenzieri, et al. "Sequential Comparison of Conventional Serum Immunofixation (IFE) to Mass Spectrometry-Based Assessment (MASS FIX) in Patients with Multiple Myeloma (MM)." Blood 136, Supplement 1 (2020): 12–13. http://dx.doi.org/10.1182/blood-2020-141342.
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Background: The absence of residual monoclonal protein in the serum and urine by IFE using specific antibodies to individual heavy and light chains has been an important part of response assessment and is required for categorizing patients as in complete response. MASS FIX has been shown to be more sensitive in picking up small amounts of monoclonal protein and represents an advancement in the field. Ongoing studies are examining the clinical significance of this increased sensitivity. We designed the following study using clinically obtained test results to examine this question. Patients and methods: The clinical laboratory at Mayo Clinic changed the process from IFE to MASS FIX in July 2018. We identified patients who had sequential testing before and after this date and collected test results from the last IFE prior to the date of transition and the first MASS FIX after the date of transition. Patients were grouped based on the paired results and outcomes compared between groups. Time to next therapy (TTNT) was defined as the time from the first MASS FIX date to the start of next therapy. Survival was estimated by the Kaplan-Meier method and these curves were compared using log rank test. Results: Overall, 739 patients with MM, who had a MASS FIX within 12 months of the IFE were studied; 380 (51%) patients had a negative IFE prior to implementation of MASS FIX. These patients had a MASS FIX test performed at a median of 3.7 (0.03-12) months from the last available IFE. The gap between IFE and MASS FIX was &lt;6 months and &lt; 3 months in 71% and 54% of the patients. Among the patients with a negative IFE, 130 (34%) tested positive on the subsequent MASS FIX. Limiting the analysis to those with a MASS FIX within 6 and 3 months yielded 32% in each group that turned positive from previous negative IFE. The median TTNT from the MASS FIX date was significantly shorter for those who became positive on MASSFIX; median was not reached for either group (P=0.002) (Figure). We then limited the analysis to those patients with a gap of &lt;6 months and &lt;3 months between the tests. The results were consistent: P= 0.012 for those with a gap of &lt; 6 months and P=0.01 for those with a gap &lt; 3 months. Conclusion: The results suggest that the additional sensitivity offered by MASS FIX have clinical significance in patients with MM, given that patients with residual disease identified by MASS FIX have an earlier relapse. The data supports the use of the more sensitive MASS FIX in the laboratory compared to the conventional IFE approaches. The study has the disadvantage that the samples were not tested simultaneously and some of the samples turning positive may reflect an early evidence of relapse, but the relative consistency of the finding irrespective of the gap between the tests argues against that. Ongoing studies are examining MASS FIX on the samples that were called to be negative by IFE initially. Figure Disclosures Murray: The Binding Site: Patents & Royalties: Patent Use of Mass Spec to identify monoclonal proteins licensed to The Binding Site. Dispenzieri:Takeda: Research Funding; Celgene: Research Funding; Janssen: Research Funding; Intellia: Research Funding; Pfizer: Research Funding; Alnylam: Research Funding. Kapoor:Cellectar: Consultancy; Sanofi: Consultancy, Research Funding; Janssen: Research Funding; Celgene: Honoraria; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding; Amgen: Research Funding. Gertz:Janssen: Other: personal fee; Spectrum: Other: personal fee, Research Funding; Springer Publishing: Patents & Royalties; Abbvie: Other; Appellis: Other: personal fee; Annexon: Other: personal fee; Celgene: Other; Amgen: Other: personal fee; Physicians Education Resource: Other: personal fee; Medscape: Other: personal fee, Speakers Bureau; Research to Practice: Other; Sanofi: Other; Teva: Speakers Bureau; Johnson and Johnson: Speakers Bureau; DAVA oncology: Speakers Bureau; Proclara: Other; Aurora Bio: Other; Prothena: Other: personal fee; Alnylam: Other: personal fee; Ionis/Akcea: Other: personal fee. Dingli:Karyopharm Therapeutics: Research Funding; Bristol Myers Squibb: Research Funding; Rigel: Consultancy; Sanofi-Genzyme: Consultancy; Millenium: Consultancy; Alexion: Consultancy; Janssen: Consultancy; Apellis: Consultancy. Lin:Janssen: Consultancy, Research Funding; Kite, a Gilead Company: Consultancy, Research Funding; Takeda: Research Funding; Gamida Cells: Consultancy; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Vineti: Consultancy; Legend BioTech: Consultancy; Merck: Research Funding; Novartis: Consultancy; Celgene: Consultancy, Research Funding; Bluebird Bio: Consultancy, Research Funding; Juno: Consultancy. Kumar:Dr. Reddy's Laboratories: Honoraria; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Carsgen: Other, Research Funding; BMS: Consultancy, Research Funding; Karyopharm: Consultancy; Tenebio: Other, Research Funding; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Adaptive Biotechnologies: Consultancy; Kite Pharma: Consultancy, Research Funding; Sanofi: Research Funding; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Merck: Consultancy, Research Funding; MedImmune: Research Funding; Cellectar: Other; Genecentrix: Consultancy; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Novartis: Research Funding.
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Mellors, Patrick, Surendra Dasari, Mindy Kohlhagen, et al. "MASS-FIX for the Diagnosis of Plasma Cell Disorders: A Single Institution Experience of 4118 Patients." Blood 136, Supplement 1 (2020): 48–49. http://dx.doi.org/10.1182/blood-2020-138829.
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Introduction: Since 2018, immunoenrichment-based matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF-MS), termed MASS-FIX, has replaced immunofixation for the detection and isotyping of serum monoclonal proteins at Mayo Clinic. MASS-FIX has advantages including increased sensitivity, specificity, and the ability to distinguish therapeutic monoclonal antibodies. Herein, we report the laboratory characteristics and distribution of diagnoses of patients tested clinically at Mayo Clinic. Methods: MASS-FIX was performed on patient samples as previously described (Kohlhagen et. al. Clin Chem Lab 2020). Demographics and laboratory data, including quantitative M-spike, serum free light chains (FLC), and quantitative immunoglobulins at the time of MASS-FIX were recorded. For patients with multiple samples during the study period, only the initial MASS-FIX was evaluated. We identified 9195 unique patients with MASS-FIX performed between 7/24/2018 and 3/6/2020. Seven-thousand nine hundred and forty-six patients provided consent for study enrollment, and 7689 had data available on index diagnosis. Given considerable variability in the interpretation of diagnostic criteria for light chain (LC) MGUS, patients with this diagnosis (1360, 18%) were excluded. Patients were considered to have negative results (2211 in total) on MASS-FIX if: 1) no monoclonal protein was identified (1081, 49%); 2) the interpretation was "cannot rule out monoclonal protein" (945, 43%); 3) multiple, nonspecific spectral peaks were identified consistent with immune reconstitution (29, 1%); or 4) the only monoclonal protein identified was consistent with a therapeutic monoclonal antibody (156, 7%). Results: The final cohort consisted of 4118 patients with a positive MASS-FIX and 2211 patients with a negative MASS-FIX, all in the setting of underlying PCDs. Figure 1 illustrates the numbers and percentages of patients who are MASS-FIX positive versus MASS-FIX negative by diagnosis. MGUS and multiple myeloma (MM) were the most common diagnoses overall, and both were more common in the MASS-FIX positive cohort. More than 90% of patients with Waldenstrom's macroglobulinemia (WM), smoldering WM, smoldering MM, and cold agglutinin disease were positive by MASS-FIX. For MASS-FIX positive patients, IgG isotype was identified in 2575 patients (63%), IgA in 703 (17%) and IgM in 710 (17%). Bence Jones proteinemia was identified in 283 patients (7%) with lambda restriction being the most common (57%). 3625 patients (88%) had a monoclonal pattern, 228 patients (6%) had a bi-clonal pattern, and 7 (&lt;1%) had a tri-clonal pattern. The majority of patients (58%) were kappa LC restricted by MASS-FIX, 222 (5%) had N-glycosylated LC, and 2 patients (&lt;1%) had a heavy chain with no light chain. Conclusions: This single institution experience illustrates the practicality of MASS-FIX in detecting and following monoclonal proteins for a wide range of PCDs in a tertiary center. In this cohort, the percentage of patients who were MASS-FIX positive varied by diagnosis, reflecting cross sectional sampling of patients throughout their disease course. Disclosures Gertz: Research to Practice: Other; Springer Publishing: Patents & Royalties; Aurora Bio: Other; Johnson and Johnson: Speakers Bureau; Sanofi: Other; Amgen: Other: personal fee; Appellis: Other: personal fee; Annexon: Other: personal fee; Spectrum: Other: personal fee, Research Funding; Janssen: Other: personal fee; Prothena: Other: personal fee; Alnylam: Other: personal fee; Ionis/Akcea: Other: personal fee; Proclara: Other; DAVA oncology: Speakers Bureau; Celgene: Other; Teva: Speakers Bureau; Abbvie: Other; Physicians Education Resource: Other: personal fee; Medscape: Other: personal fee, Speakers Bureau. Kumar:AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Dr. Reddy's Laboratories: Honoraria; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Carsgen: Other, Research Funding; Karyopharm: Consultancy; Merck: Consultancy, Research Funding; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Kite Pharma: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Genecentrix: Consultancy; Adaptive Biotechnologies: Consultancy; Novartis: Research Funding; MedImmune: Research Funding; Sanofi: Research Funding; Tenebio: Other, Research Funding; Cellectar: Other; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments. Kapoor:Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding; Cellectar: Consultancy; Janssen: Research Funding; Celgene: Honoraria. Dingli:Karyopharm Therapeutics: Research Funding; Bristol Myers Squibb: Research Funding; Rigel: Consultancy; Alexion: Consultancy; Sanofi-Genzyme: Consultancy; Janssen: Consultancy; Apellis: Consultancy; Millenium: Consultancy. Lin:Merck: Research Funding; Legend BioTech: Consultancy; Juno: Consultancy; Bluebird Bio: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Novartis: Consultancy; Janssen: Consultancy, Research Funding; Kite, a Gilead Company: Consultancy, Research Funding; Gamida Cells: Consultancy; Takeda: Research Funding; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Vineti: Consultancy. Murray:The Binding Site: Patents & Royalties: Patent Use of Mass Spec to identify monoclonal proteins licensed to The Binding Site. Dispenzieri:Alnylam, Intellia, Janssen, Takeda, Pfizer, Prothena, Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding.
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Lacy, Martha Q., Kah-Whye Peng, Stephen J. Russell, et al. "Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients with Relapsed or Refractory Multiple Myeloma (MM), Acute Myeloid Leukemia (AML), and T-Cell Neoplasms (TCL)." Blood 132, Supplement 1 (2018): 3268. http://dx.doi.org/10.1182/blood-2018-99-119444.
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Abstract Background: We previously reported successful treatment of myeloma with an oncolytic virus, MMV-NIS. Preexisting immunity against measles made use of that virus unsatisfactory. The Indiana strain of Vesicular Stomatitis Viruses (VSV) are being developed as anticancer drugs for the treatment of a variety of malignancies. To ensure tumor selective replication and spread, we designed the VSV to encode interferon beta. Expression of IFNβ also serves as a STING agonist to activate host immunity against the cancer. The sodium iodide symporter (NIS) is inserted as a reporter gene into the viral genome to enable noninvasive monitoring of viral spread using PET/CT imaging. We report a Phase I clinical trial of intravenous administration of VSV-IFNβ-NIS for relapsed hematological malignancies including MM, AML, and TCL. Methods: Arm A consisted of patients with low tumor burden. Arm B included patients with high tumor burden. Both arms consisted of a classical 3+3 phase I trial, starting at 5x10^9 TCID50 (dose level 1) through 5x10^11 TCID50 (dose level 4), given as a single IV dose. In order to obviate potential toxicity from high interferon levels, Arm B received ruxolitinib 15 mg twice daily for 10 days beginning on day -1. The primary objective was determining the maximum tolerated dose (MTD) of VSV-IFNβ-NIS alone and in combination with ruxolitinib; secondary objectives include estimating the safety profile and preliminary efficacy. Correlative objectives include monitoring the pharmacodynamics of viral replication through SPECT/CT imaging with NIS gene, viremia, virus shedding, changes in the immune profile of peripheral blood leukocytes, and immunohistochemistry for immune cell infiltrates in tumors. Adverse events (AEs) are reported herein based on CTCAE v4 with the exception of cytokine release syndrome (CRS) which is based on Lee (Blood 2014; 124(2):188-195) criteria. Results: To date, 10 patients have received IV VSV-IFNβ-NIS; 8 in Arm A and 2 in Arm B. In Arm A, 3 patients were treated at dose level 1, 3 at dose level 2 and 2 at dose level 3. At dose level 1, there were three grade 3 hematologic AEs (neutropenia [1], lymphopenia [2]), and no grade 3+ non-hematologic AEs. At dose level 2, there were two grade 3 hematologic AEs (anemia [1], lymphopenia [1]), and two grade 3 non-hematologic AEs (nausea [1], dehydration [1]). A grade 2 CRS by Lee criteria was also observed. At dose level 3, 2 patients have been enrolled and data are maturing for DLT evaluation. In Arm B (VSV + rux), 2 patients have been enrolled and data are maturing for dose limiting toxicity (DLT) evaluation. Other grade 1 and 2 toxicities have included fever, hypertension, headache, electrolyte abnormalities, nausea, vomiting, transient elevation of liver function tests and creatinine. All grade 1 and 2 toxicities resolved within 72 hours. Among the 6 patients evaluable for response, there was one partial remission (TCL patient treated at dose level 2), and 5 with progressive disease. Multiple cytokines increased at 4h post infusion of virus, but most returned to baseline levels by 24h.Viremia was detectable in all patients at the end of infusion, and to varying levels at 30 mins, 1, 2, 4, 24, 48h or 72 hours post virus infusion. No persistent viremia was observed. No infectious virus was recovered in buccal swabs or urine and neutralizing anti-VSV antibodies were present by day 29. Extensive immune phenotyping and ELIspot assays for shared antigens are ongoing. Conclusion: In the lowest dose levels tested to date, VSV-IFNβ-NIS has not led to any observed dose limiting toxicity. Dose escalation is ongoing and updated results will be reported. Disclosures Lacy: Celgene: Research Funding. Peng:Vyriad: Equity Ownership. Russell:Vyriad: Equity Ownership. Dueck:Bayer: Employment; Phytogine: Employment; Pfizer: Honoraria. Witzig:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Dispenzieri:Celgene, Takeda, Prothena, Jannsen, Pfizer, Alnylam, GSK: Research Funding. Gertz:spectrum: Consultancy, Honoraria; Physicians Education Resource: Consultancy; Ionis: Honoraria; janssen: Consultancy; Medscape: Consultancy; celgene: Consultancy; Apellis: Consultancy; Prothena: Honoraria; Amgen: Consultancy; annexon: Consultancy; Abbvie: Consultancy; Research to Practice: Consultancy; Teva: Consultancy; Alnylam: Honoraria. Dingli:Alexion Pharmaceuticals, Inc.: Other: Participates in the International PNH Registry (for Mayo Clinic, Rochester) for Alexion Pharmaceuticals, Inc.; Millennium Takeda: Research Funding; Alexion Pharmaceuticals, Inc.: Other: Participates in the International PNH Registry (for Mayo Clinic, Rochester) for Alexion Pharmaceuticals, Inc.; Millennium Takeda: Research Funding. Kapoor:Celgene: Research Funding; Takeda: Research Funding. Al-Kali:Novartis: Research Funding. Naik:Vyriad: Equity Ownership. Kumar:AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; KITE: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; KITE: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Merck: Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Research Funding; AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding.
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Mellors, Patrick, Surendra Dasari, Mindy Kohlhagen, et al. "A Cross Sectional Evaluation of Light Chain N-Glycosylation By MASS-FIX in Plasma Cell Disorders." Blood 136, Supplement 1 (2020): 44–45. http://dx.doi.org/10.1182/blood-2020-142601.
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Introduction: Since 2018, immunoenrichment-based matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF-MS), termed MASS-FIX, has replaced standard gel-based immunofixation for the detection and isotyping of serum monoclonal proteins at Mayo Clinic. MASS-FIX can readily identify N-glycosylation of involved light chains (LC N-glycosylation) by its unique, polytypic spectral pattern. LC N-glycosylation is identified more commonly in light chain amyloidosis (AL) than other plasma cell disorders (PCDs), and is associated with an increased risk of progression from MGUS to both AL and other PCDs (Dispenzieri et. al. Leukemia 2020). Herein, we report the mass spectral characteristics and distribution of diagnoses among 222 patients with LC N-glycosylation detected during a 20 month period in our clinical lab. Methods: MASS-FIX was performed on patient samples as previously described (Kohlhagen et. al. Clin Chem Lab 2020). Demographics and laboratory data, including quantitative M-spike, serum free light chains (FLC), and quantitative immunoglobulins at the time of MASS-FIX were recorded. For patients with multiple samples during the study period, only the initial MASS-FIX was evaluated. 9195 unique patients had MASS-FIX performed from 7/24/2018 to 03/06/2020. Inclusion criteria for this retrospective study included: 1) consent for record review; 2) a monoclonal protein identified on MASS-FIX; 3) an underlying PCD. Patients were considered to have negative results (2211 in total) on MASS-FIX if: 1) no monoclonal protein was identified (1081, 49%); 2) the interpretation was "cannot rule out monoclonal protein" (945, 43%); 3) multiple, nonspecific spectral peaks were identified consistent with immune reconstitution (29, 1%); or 4) the only monoclonal protein identified was consistent with a therapeutic monoclonal antibody (156, 7%). The final positive cohort consisted of 4118 patients with definitive monoclonal proteins on MASS-FIX. Results: Two-hundred and twenty-two (5%) of the 4118 patients with a positive MASS-FIX had LC N-glycosylation. 202 patients (91%) had FLC assays performed. Of these, 110 (54%) were kappa LC restricted, 22 (11%) were lambda restricted, and 70 (35%) were normal. A quantifiable M-spike was identified in 110 patients (85%) of 129 patients who had serum protein electrophoresis performed. By MASS-FIX, 139 patients (63%) had an IgG isotype, 18 (8%) an IgA, and 55 (25%) an IgM. Two of these patients had a bi-clonal pattern in which both IgG kappa and IgM kappa LCs were N-glycosylated. 12 patients (5%) had monoclonal light chains with no corresponding heavy chain. Overall, 173 (78%) of 222 patients were kappa LC restricted and 44 (22%) were lambda. 189 patients (85%) had a monoclonal pattern, 18 (8%) had a bi-clonal pattern, and 3 (1%) had a tri-clonal pattern. The most common PCD diagnoses for the 222 patients with LC N-glycosylation were MGUS (45%), multiple myeloma (MM) (31%), and immunoglobulin light chain amyloidosis (AL) (8%). The percentage of MASS-FIX positive patients with LC N-glycosylation by diagnosis, stratified by kappa and lambda LC restriction, is illustrated in Figure 1. Cold agglutinin disease (CAD) had the highest relative percentage of patients with LC N-glycosylation, regardless of LC restriction. Eighteen AL patients (5%) had LC N-glycosylation; the percentage was higher in kappa restricted (13%) than lambda restricted AL patients (2%). Of note, LC N-glycosylation was not detected in patients with plasma cell leukemia, non-AL amyloidosis with associated MGUS, POEMS Syndrome or Castleman's Disease in this cross sectional sampling of patients. Conclusions: This retrospective study demonstrates that 5% of patients in a routine clinical setting with positive MASS-FIX have glycosylated LCs. Consistent with prior observations, CAD had the highest relative percentage of LC N-glycosylated patients. The percentage of AL patients with LC N-glycosylation in this cohort is lower than previously reported for newly diagnosed AL patients (Kumar et. al. Leukemia 2019), which is not surprising given that the current cohort study is a cross sectional evaluation of patients at various stages of diagnosis and treatment rather than a prevalence study. Further study will be done to exclude the presence of latent AL in patients with N-glycosylated LC and diagnoses of MGUS, SMM, MM, and Waldenstrom's macroglobulinemia. Disclosures Gertz: Springer Publishing: Patents & Royalties; Proclara: Other; DAVA oncology: Speakers Bureau; Johnson and Johnson: Speakers Bureau; Teva: Speakers Bureau; Sanofi: Other; Research to Practice: Other; Celgene: Other; Abbvie: Other; Physicians Education Resource: Other: personal fee; Medscape: Other: personal fee, Speakers Bureau; Amgen: Other: personal fee; Appellis: Other: personal fee; Annexon: Other: personal fee; Spectrum: Other: personal fee, Research Funding; Janssen: Other: personal fee; Prothena: Other: personal fee; Alnylam: Other: personal fee; Ionis/Akcea: Other: personal fee; Aurora Bio: Other. Kumar:Adaptive Biotechnologies: Consultancy; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Carsgen: Other, Research Funding; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Dr. Reddy's Laboratories: Honoraria; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Merck: Consultancy, Research Funding; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; MedImmune: Research Funding; Genecentrix: Consultancy; Tenebio: Other, Research Funding; Karyopharm: Consultancy; BMS: Consultancy, Research Funding; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Sanofi: Research Funding; Novartis: Research Funding; Kite Pharma: Consultancy, Research Funding; Cellectar: Other. Kapoor:Janssen: Research Funding; Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding; Celgene: Honoraria; Cellectar: Consultancy. Dingli:Alexion: Consultancy; Karyopharm Therapeutics: Research Funding; Bristol Myers Squibb: Research Funding; Janssen: Consultancy; Sanofi-Genzyme: Consultancy; Apellis: Consultancy; Rigel: Consultancy; Millenium: Consultancy. Lin:Janssen: Consultancy, Research Funding; Novartis: Consultancy; Celgene: Consultancy, Research Funding; Bluebird Bio: Consultancy, Research Funding; Juno: Consultancy; Legend BioTech: Consultancy; Merck: Research Funding; Takeda: Research Funding; Gamida Cells: Consultancy; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Vineti: Consultancy; Kite, a Gilead Company: Consultancy, Research Funding. Murray:The Binding Site: Patents & Royalties: Patent Use of Mass Spec to identify monoclonal proteins licensed to The Binding Site. Dispenzieri:Intellia: Research Funding; Pfizer: Research Funding; Takeda: Research Funding; Celgene: Research Funding; Janssen: Research Funding; Alnylam: Research Funding.
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Ezeana, Chika, Xiaohui Yu, Zhihao Wan, et al. "Abstract PO2-28-06: An on-line deep learning decision support tool, iBRISK, aimed at improving breast cancer risk estimation and reducing unnecessary biopsies for BI-RADS 4 patients." Cancer Research 84, no. 9_Supplement (2024): PO2–28–06—PO2–28–06. http://dx.doi.org/10.1158/1538-7445.sabcs23-po2-28-06.
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Abstract Probability of malignancy (POM) for Breast Imaging Reporting and Data System (BI-RADS) category 4 designated breast lesions ranges from 2% – 95% and contributes to a high unnecessary biopsy rate. This is as most clinicians often stick to the biopsy option to rule in or out breast cancer early; withholding biopsy could be risky, and biopsies of BI-RADS 4 lesions serve as a quality metric and performance standard. At 21.1%, biopsy-proven positive predictive value (PPV3) rates for BI-RADS 4 have not improved for decades, translating to high false-positive rates of mammography. Unnecessary biopsies are a big issue in the management of BI-RADS 4 lesions with negative implications including increased medical costs, healthcare wastes, unnecessary psychological burdens to the patients, and potential complications and risks. Objectives 1. Optimize the precision breast cancer risk assessment tool, iBRISK, that utilizes artificial intelligence (AI) technologies, including natural language processing (NLP), image processing, and deep learning, with clinical risk factors and imaging features. 2. Develop a user-friendly web interface for iBRISK to facilitate clinicians or insurers in estimating cancer risk and making informed biopsy decisions for BI-RADS 4 lesions. Methods Our intelligent-augmented breast cancer risk calculator (iBRISK) model was trained on multimodal data collected from 10,778 patients, including demographic factors, historical and clinical characteristics, mammographic features, and pathologic signatures. We validated iBRISK using 4,200 patients from multiple leading hospitals, including Houston Methodist Neal Cancer Center, the University of Texas MD Anderson Cancer Center, and the University of Texas Health San Antonio MD Anderson Mays Cancer Center. The iBRISK was connected to a backend server which is linked to a frontend web user interface using technologies like Hypertext Preprocessor (PHP) for the backend application running on an APACHE HTTP server and React-JavaScript for the front-end web application that communicates with the backend using Representational State Transfer Application Programming Interface (RESTful API) and JavaScript Object Notation (JSON) format. The communication was secured using Secure Sockets Layer (SSL) encryption. Results The iBRISK model demonstrated high sensitivity in malignancy prediction and achieved an accuracy of 89.5%, area under the receiver operating characteristic curve of 0.93 (95% CI: 0.92-0.95), sensitivity of 100%, and specificity of 81%. Only 0.16% of lesions determined to have low POM by the model were malignant. Our multi-center study shows that iBRISK achieves at least 50% reduction in unnecessary biopsies of BI-RADS 4 cases. Data elements for the required 20 features are entered into the interface using a variety of imputation methods including direct text, dropdown menus and radio button selections. The user-friendly web interface provides risk scores (0 – 1), risk levels (low, medium, and high), and associated biopsy recommendations. Conclusion The user-friendly iBRISK web interface is proposed as an adjunct to the BI-RADS system, enhancing the precision of BI-RADS 4 lesion cancer risk stratification. It is expected to reduce unnecessary biopsies, lower health costs, and enhance the quality of health care. This approach aims to tackle a critical issue in breast cancer diagnosis by leveraging advanced AI technologies and big data and providing clinicians with a tool to make more informed and precise biopsy decisions for BI-RADS 4 lesions. Citation Format: Chika Ezeana, Xiaohui Yu, Zhihao Wan, Tiancheng He, Tejal Patel, Virginia Kaklamani, Maryam Elmi, Erika Brigmon, Pamela Otto, Kenneth Kist, Lin Wang, Joe Ensor, Heather Speck, Ya-Chen Shih, Bumyang Kim, I-Wen Pan, David Spak, Wei Yang, Jenny Chang, Stephen Wong. An on-line deep learning decision support tool, iBRISK, aimed at improving breast cancer risk estimation and reducing unnecessary biopsies for BI-RADS 4 patients [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-28-06.
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Vachon, Celine M., Josiah Murray, Cristine Allmer, et al. "Comparison of MGUS Prevalence By Race and Family History Risk Groups Using a High Sensitivity Screening Method (MASS-FIX)." Blood 136, Supplement 1 (2020): 40–41. http://dx.doi.org/10.1182/blood-2020-142583.
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Introduction Monoclonal gammopathy of undetermined significant (MGUS) is a premalignant plasma cell disorder that is common in individuals over age 50. MGUS prevalence estimates to date have generally been based on results of serum electrophoresis and immunofixation (for heavy chain [HC] MGUS) and additionally, free light chain (for light chain [LC] MGUS). Mass-spectrometry assays, however, can detect lower levels of monoclonal (M) proteins, identify the isotype and provide accurate quantification of the M-protein. Given the evidence that MGUS is likely present at least 10 years prior to its detection, mass spectrometry may provide more accurate estimates of underlying MGUS. We examined the prevalence of HC-MGUS using matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry among three risk groups: European Americans (EA), African Americans (AA) and first-degree relatives (FDR) of patients with multiple myeloma (MM), MGUS, chronic lymphocytic leukemia (CLL) or non-Hodgkin's lymphoma (NHL). Methods We sampled all AA and a random sample of EA participants ages 50 and older enrolled in the Mayo Clinic Biobank. We also selected unaffected first-degree relatives (limiting to ages 50 and older) from our ongoing family study of hematological malignancies. We screened serum samples by the MALDI-TOF mass spectrometry assay, which is clinically used at Mayo Clinic (known as MASS-FIX) for detection and isotypes of M-proteins. The assay uses isotype-specific nanobody enrichment coupled to MALDI-TOF mass spectrometry. For each of the risk groups, HC- MGUS prevalence was estimated by age (50-59, 60-69, 70+). Age- and sex-adjusted prevalence rates were calculated by direct standardization to the 2010 US population. Ninety-five percent confidence intervals (95% CI) for the prevalence rates and comparisons across the three groups were based on the Poisson distribution. Because free LC information was unavailable, LC-MGUS was not estimated. Results A total 327 AA, 854 EA and 792 FDR were screened for M-proteins using the MASS-FIX assay. All three groups had similar sex (42-44% male) and age distributions (mean[SD] age was 64.5[9.5] yrs., 64.4[8.8] yrs. and 64.9[10.5] yrs. for AA, EA and FDR, respectively). As previously noted using conventional detection methods, the overall prevalence of HC-MGUS was higher in the AA population (16.5% [95%CI: 12.2%, 20.8%]) and FDR (21.5% [95%CI: 18.3%, 24.7%]) than in EA (11.2% [95%CI: 8.8%, 13.5%]), both p-values &lt;0.0001. This pattern was generally seen across age groups (Table 1), with increasing prevalence with age. FDR of MM or MGUS cases had a higher prevalence (22.2% [95%CI: 18.4%, 26.0%]) than FDR of CLL or NHL cases (18.8% [95%CI: 13.3%, 24.4%]), although the difference was not statistically significant (p-value=0.82). Overall prevalence estimates of HC-MGUS using MASS-FIX were at least three-fold higher than estimates using conventional methods alone (i.e. age- and sex-adjusted prevalence in Olmsted County, MN, was 3.1% [95% CI: 2.9%-3.4%]). Conclusion We provided some of the first data on prevalence of HC-MGUS across three risk groups, using a sensitive method for detecting monoclonal proteins. The MASS-FIX assay resulted in substantially higher absolute rates of HC-MGUS (at least 3-fold higher) relative to conventional methods. Further, the prevalence of HC-MGUS among the AA and FDR was significantly higher than the EA population. Thus, the more sensitive assay identified greater absolute numbers of individuals with MGUS, but resulted in similar relationships as seen in prior studies across these risk groups. Our results have implications for future studies of the etiology of MGUS and its progression. Disclosures Dispenzieri: Janssen: Research Funding; Pfizer: Research Funding; Alnylam: Research Funding; Intellia: Research Funding; Celgene: Research Funding; Takeda: Research Funding. Kumar:Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Karyopharm: Consultancy; Genecentrix: Consultancy; Cellectar: Other; Carsgen: Other, Research Funding; Merck: Consultancy, Research Funding; Dr. Reddy's Laboratories: Honoraria; Adaptive Biotechnologies: Consultancy; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Kite Pharma: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Tenebio: Other, Research Funding; Sanofi: Research Funding; MedImmune: Research Funding; Novartis: Research Funding. Murray:The Binding Site: Patents & Royalties: Patent Use of Mass Spec to identify monoclonal proteins licensed to The Binding Site.
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Cook, Joselle, Kah-Whye Peng, Brenda F. Ginos, et al. "Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon Beta, in Patients with Relapsed or Refractory Multiple Myeloma (MM), Acute Myeloid Leukemia (AML), and T-Cell Neoplasms (TCL)." Blood 136, Supplement 1 (2020): 7–8. http://dx.doi.org/10.1182/blood-2020-140853.
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Background: Oncolytic virotherapy is a novel immunomodulatory therapeutic approach for relapsed refractory hematologic malignancies. The Indiana strain of Vesicular Stomatitis Virus (VSV) has been engineered to encode interferon beta (IFNβ) and sodium iodine symporter (NIS) to produce VSV-IFNβ-NIS. The virally encoded IFNβ serves as an index of viral proliferation and enhances host anti-tumor immunity. The NIS is inserted as a reporter gene into the viral genome to enable noninvasive monitoring of viral spread using PET/CT imaging. Here we present results of Arm A (patients with low tumor burden) of the Phase I clinical trial (NCT03017820) of intravenous administration of VSV-IFNβ-NIS for patients (pts) with relapsed refractory hematological malignancies: MM, AML, and TCL. Methods: This was a classical 3+3 phase I trial, starting at 5x10^9 TCID50 (50% tissue culture infectious dose) level 1 through 1.7x10^11 TCID50 dose level 4 given as a single IV dose. The primary objective was determining the maximum tolerated dose of VSV-IFNβ-NIS alone; secondary objectives include estimating the safety profile and preliminary efficacy. Correlative objectives include monitoring the pharmacodynamics of viral replication through SPECT/CT imaging with NIS gene, viremia, virus shedding and changes in the immune profile of peripheral blood leukocytes. Adverse events (AEs) are reported based on CTCAE v4; cytokine release syndrome (CRS) grading was based on Lee (Blood 2014; 124(2):188-195) criteria. Results: From April 2017, 12 pts have received IV VSV-IFNβ-NIS in Arm A: MM (7), TCL(4) and AML(1); 3 pts were treated at each dose level (DL) 1 to 4. At DL1, there were five grade 3 hematologic AEs (leukopenia [1], neutropenia [1], lymphopenia [3]) and no grade 3+ non-hematologic AEs. At DL2, three grade 3 hematologic AEs (anemia [2], lymphopenia [1]), four grade 4 hematologic AEs (neutropenia [1], leukopenia [1], lymphopenia [1] and thrombocytopenia [1]). There was 1 event of grade 2 CRS at DL2, two grade 3 non-hematologic AEs (nausea [1], dehydration [1]). At DL3, there was one grade 4 hematologic AE (neutropenia [1]), three grade 3 hematologic AEs (lymphopenia [2], leukopenia [1]), and one grade 3 non-hematologic AE (vasovagal reaction [1]). One grade 2 and grade 1 CRS by Lee criteria were observed. At DL4, there were three grade 3 hematologic AEs (lymphopenia [1], neutropenia [1], thrombocytopenia [1]), and three grade 3 non-hematologic AEs (AST increase [1], skin infection [1], soft tissue infection [1])and two grade 2 CRS. There were no dose limiting toxicities. There was one partial response (DL2) and one complete response (DL4); 3 pts had stable disease, 7 pts progressed. The MM pts receiving VSV-IFNβ-NIS at DL4 had stable disease. Six of the 7 MM pts demonstrated transient reduction in serum level of involved free light chain (LC) after VSV-IFNβ-NIS infusion, with median 20.4% reduction of the involved LC within 48 hrs. Viremia was detectable in all pts at the end of infusion, to varying levels at 30 mins, 1, 2, 4, 24, 48h or 72 hrs post infusion. No persistent viremia was observed. No infectious virus was recovered in buccal swabs or urine and neutralizing anti-VSV antibodies were present by day 29. The IFN levels were detectable within 30 minutes of infusion and peaked between 4 and 48 hrs. The pts with a diagnosis of TCL mounted higher hIFNβ levels within 48 hrs. Remarkably, the TCL pt with CR (DL4) mounted a peak hIFNβ response of 18213.3pg/ml at 48 hrs post infusion, approximately 15-fold higher than any other pt enrolled in the study; and highest neutralizing antibody titer (1:40960). Conclusion: VSV-IFNβ-NIS can be safely administered by intravenous infusion in pts with hematological malignancies, up to a dose level of 1.7 x 1011 TCID50, without dose limiting toxicities and no CRS higher than grade 2. In this small phase 1 study, pts with T-cell lymphoma demonstrated the strongest signal of response, with one confirmed partial response at DL2 and one complete response at DL4. IFNβ is an early biomarker of tumor susceptibility; the magnitude of IFNβ elevation appears to correlate with treatment response. There were no confirmed responses in pts with MM, but the 20.4% transient reduction in LC suggests that combination strategies with VSV-IFNβ-NIS may result in deeper and sustained responses in MM. Future trials investigating combination strategies with immune modulatory drugs are being planned. Disclosures Peng: Imanis: Other: Equity Ownership. Witzig:Karyopharm Therapeutics: Research Funding; Immune Design: Research Funding; Spectrum: Consultancy; Incyte: Consultancy; Acerta: Research Funding; MorphSys: Consultancy; AbbVie: Consultancy; Celgene: Consultancy, Research Funding. Dispenzieri:Intellia: Research Funding; Pfizer: Research Funding; Takeda: Research Funding; Alnylam: Research Funding; Janssen: Research Funding; Celgene: Research Funding. Gertz:Celgene: Consultancy; Annexon: Consultancy; Sanofi: Consultancy; Appellis: Consultancy; Amgen: Consultancy; Medscape: Consultancy, Speakers Bureau; Physicians Education Resource: Consultancy; Data Safety Monitoring board from Abbvie: Membership on an entity's Board of Directors or advisory committees; NCI SPORE MM: Research Funding; Johnson and Johnson: Speakers Bureau; Springer Publishing: Patents & Royalties; Amyloidosis Foundation: Research Funding; Advisory Board for Proclara: Membership on an entity's Board of Directors or advisory committees; Alnylam: Consultancy; Ionis/Akcea: Consultancy; Spectrum: Consultancy, Research Funding; Prothena: Consultancy; DAVA oncology: Speakers Bureau; i3Health: Consultancy; Advisory Board for Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy; International Waldenstrom Foundation: Research Funding. Dingli:Rigel: Consultancy; Bristol Myers Squibb: Research Funding; Janssen: Consultancy; Alexion: Consultancy; Apellis: Consultancy; Karyopharm Therapeutics: Research Funding; Millenium: Consultancy; Sanofi-Genzyme: Consultancy. Kapoor:Cellectar: Consultancy; Celgene: Honoraria; Janssen: Research Funding; Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding. Lin:Janssen: Consultancy, Research Funding; Kite, a Gilead Company: Consultancy, Research Funding; Legend BioTech: Consultancy; Juno: Consultancy; Bluebird Bio: Consultancy, Research Funding; Novartis: Consultancy; Celgene: Consultancy, Research Funding; Merck: Research Funding; Takeda: Research Funding; Gamida Cells: Consultancy; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Vineti: Consultancy. Kumar:Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Cellectar: Other; Carsgen: Other, Research Funding; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Merck: Consultancy, Research Funding; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Sanofi: Research Funding; Dr. Reddy's Laboratories: Honoraria; Adaptive Biotechnologies: Consultancy; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Kite Pharma: Consultancy, Research Funding; Novartis: Research Funding; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; MedImmune: Research Funding; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Karyopharm: Consultancy; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; BMS: Consultancy, Research Funding; Genecentrix: Consultancy; Tenebio: Other, Research Funding. Russell:Imanis: Other: Equity Ownership. OffLabel Disclosure: This describes of administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and human interferon, in Patients with Relapsed or Refractory Hematologic malignacies
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M R, Shincy, Vandana Govindan, Sudhakar H H, Padmapriya K, Venkatesha V T, and K. L. Ravikumar. "COMPARISON OF PERFORMANCE CHARACTERISTICS BETWEEN LATERAL FLOW, ELISAAND ELECTROCHEMILUMINESCENCE IMMUNOASSAYS FOR THE DETECTION OF SARS-COV-2 ANTIBODIES AMONG HEALTHCARE WORKERS." INTERNATIONAL JOURNAL OF SCIENTIFIC RESEARCH, July 1, 2021, 45–48. http://dx.doi.org/10.36106/ijsr/0101617.
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Background: The detection of SARS-CoV-2 IgG is important to determine the course of COVID-19. Medical professionals and researchers have been urging the need for wide and rapid testing of citizens in order to plan measures that can contain the spread of the virus. Antibody tests play an important role throughout the patient care pathway and are vital for the management and surveillance of the virus. Although RTPCR is considered to be the gold standard, serological tests based on antibodies could be very helpful for on-time detection. We performed one to one assessment of electrochemiluminescence immunoassay, enzyme immunoassay (EIAs), and point-of-care lateral ow assay (POCTs) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibody. Materials and Methods: 611 healthcare workers were recruited between November and December 2020 at Central Research Laboratory, KIMS. ® Collected serum samples were analysed using three commercially available assays: the Elecsys , Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assay following the manufacturer's protocol to measure the IgG titer of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Results:The kits displayed a sensitivity of 91.8%, 79.5% ,61.2% and a specicity of 80.2%, 64.1% ,61.7% in order. Conclusion: ® Our results indicate a high sensitivity and specicity for the Elecsys assay compared to Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assays.
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"Children's Museum Hosts ‘Golf Fore Kids’." Special Events Galore 17, no. 2 (2017): 5. http://dx.doi.org/10.1002/speg.30507.
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"Men in Kilts: A Fun Crowdfunding Campaign." Special Events Galore 19, no. 9 (2019): 7. http://dx.doi.org/10.1002/speg.31187.
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"Follow the KISS Model: “Keep It Simply Sustainable”." Special Events Galore 22, no. 10 (2022): 4. http://dx.doi.org/10.1002/speg.31850.
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"Downright Beautiful Fashion Show Features Down Syndrome Kids." Special Events Galore 18, no. 1 (2017): 7. http://dx.doi.org/10.1002/speg.30744.
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"800 Participate in ‘Kids Are No. 1’ Event." Special Events Galore 19, no. 10 (2019): 3. http://dx.doi.org/10.1002/speg.31202.
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Mukherjee, Archana. "An Update on Extemporaneous Preparation of Radiopharmaceuticals Using Freeze-Dried Cold Kits." Mini-Reviews in Medicinal Chemistry 20 (December 14, 2020). http://dx.doi.org/10.2174/1389557520999201214233634.
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Abstract:: The field of nuclear medicine is rapidly evolving due to the high demand of radiopharmaceuticals for diagnostic and therapeutic applications. The availability of a vast array of radioisotopes, improvement in radiolabeling strategies, and advancements in detection systems have also contributed to the progress in this field. Radiopharmaceuticals are mainly classified based on their application as diagnostic or therapeutic radiopharmaceuticals. These are available either as ready to use preparations or prepared at hospital radiopharmacy either using automated synthesis modules or by using freeze-dried cold kit formulations. Availability of freeze-dried cold kits for preparation of varied radiopharmaceuticals for targeting various organs and tissues played an essential role in the extensive use of 99mTc radiopharmaceuticals for diagnostic imaging by single-photon emission computed tomography (SPECT) imaging. Cold kits are especially suitable for the preparation of radiopharmaceuticals labeled with isotopes like 177Lu with relatively long half-life or radionuclides produced by radioisotope generators. A simplified procedure for the preparation of positron emission tomography (PET) radiopharmaceuticals is also desired to achieve images with higher resolution and sensitivity offered by PET. Robust kit formulations will simplify the preparation of PET radiopharmaceuticals and will contribute to extensive applications of positron emitters such as 68Ga. Several therapeutic radiopharmaceuticals are also being made using cold kits of the ligands. This review provides an update on diagnostic and therapeutic radiopharmaceuticals prepared using cold kits.