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Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
Radiopharmaceuticals and Contrast Media – Oxford Clinical Policy
UnitedHealthcare® Oxford Clinical Policy Radiopharmaceuticals and Contrast Media Policy Number: RADIOLOGY 034.19 T0 Effective Date: January 1, 2021 Instructions for Use Table of Contents Page Related Policies Coverage Rationale ....................................................................... 1 • Cardiology Procedures Requiring Prior Definitions .................................................................................... 10 Authorization for eviCore Healthcare Arrangement Prior Authorization Requirements .............................................. 10 • Radiation Therapy Procedures Requiring Prior Applicable Codes ........................................................................ 10 Authorization for eviCore Healthcare Arrangement Description of Services ............................................................... 13 • Radiology Procedures Requiring Prior Authorization References ................................................................................... 13 for eviCore Healthcare Arrangement Policy History/Revision Information ........................................... 14 Instructions for Use ..................................................................... 14 Coverage Rationale eviCore healthcare administers claims on behalf of Oxford Health Plans for the following services that may be billed in conjunction with radiopharmaceuticals and/or contrast media: • Radiology Services: Refer to Radiology Procedures Requiring Prior Authorization for eviCore Healthcare Arrangement for additional information. -
208054Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208054Orig1s000 MEDICAL REVIEW(S) Clinical Review Phillip B. Davis, MD Priority Review 505(b)(2) NDA Axumin (18F-Fluciclovine) CLINICAL REVIEW Application Type 505 (b) (1) Application Number(s) 208054 Priority or Standard Priority Review Submit Date(s) 9/28/2015 Received Date(s) 9/28/2015 PDUFA Goal Date 5/27/2016 Division/Office DMIP/ODEIV Reviewer Name(s) Phillip B. Davis, MD Review Completion Date 2/26/2016 Established Name 18F-Fluciclovine (Proposed) Trade Name Axumin Applicant Blue Earth Diagnostics Formulation(s) Solution Dosing Regimen 10mCi via intravenous injection Applicant Proposed PET Imaging men with suspected prostate cancer recurrence. Indication(s)/Population(s) Recommendation on Approval Regulatory Action Recommended Positron emission tomography (PET) imaging of men with Indication(s)/Population(s) suspected prostate cancer recurrence. Axumin PET imaging may (if applicable) identify sites of prostate cancer. CDER Clinical Review Template 2015 Edition 1 Version date: June 25, 2015 for initial rollout (NME/original BLA reviews) Reference ID: 3897370 Clinical Review Phillip B. Davis, MD Priority Review 505(b)(2) NDA Axumin (18F-Fluciclovine) Table of Contents Glossary .................................................................................................................................. 8 1 Executive Summary .........................................................................................................10 1.1. Product Introduction ................................................................................................10 -
The Role of 18F-Flortaucipir (AV-1451) in the Diagnosis of Neurodegenerative Disorders
Open Access Review Article DOI: 10.7759/cureus.16644 The Role of 18F-Flortaucipir (AV-1451) in the Diagnosis of Neurodegenerative Disorders Saswata Roy 1 , Dipanjan Banerjee 2, 3 , Indrajit Chatterjee 4 , Deepika Natarajan 5 , Christopher Joy Mathew 2 1. General Medicine, Musgrove Park Hospital, Taunton, GBR 2. Internal Medicine, East Sussex Healthcare NHS Trust, Hastings, GBR 3. Neuroscience, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA 4. General Psychiatry, Wishaw University Hospital, Hamilton, GBR 5. General Surgery, North Cumbria Integrated Care (NCIC), Carlisle, GBR Corresponding author: Saswata Roy, [email protected] Abstract Tau protein plays a vital role in maintaining the structural and functional integrity of the nervous system; however, hyperphosphorylation or abnormal phosphorylation of tau protein plays an essential role in the pathogenesis of several neurodegenerative disorders. The development of radioligand such as the 18F- flortaucipir (AV-1451) has provided us with the opportunity to assess the underlying tau pathology in various etiologies of dementia. For the purpose of this article, we aimed to evaluate the utility of 18F-AV- 1451 in the differential diagnosis of various neurodegenerative disorders. We used PubMed to look for the latest, peer-reviewed, and informative articles. The scope of discussion included the role of 18F-AV-1451 positron emission tomography (PET) to aid in the diagnosis of Alzheimer’s disease (AD), frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and Parkinson’s disease with dementia (PDD). We also discussed if the tau burden identified by neuroimaging correlated well with the clinical severity and identified the various challenges of 18F-AV-1451 PET. -
[18F] FACBC (Fluciclovine) PET-CT of Breast Cancer an Exploratory Study
Journal of Nuclear Medicine, published on April 7, 2016 as doi:10.2967/jnumed.115.171389 Anti-3-[18F] FACBC (Fluciclovine) PET-CT of Breast Cancer: An Exploratory Study Funmilayo I. Tade1, Michael A. Cohen1, Toncred M. Styblo2, Oluwaseun A. Odewole1, Anna I. Holbrook1, Mary S. Newell1, Bital Savir-Baruch3, Xiaoxian Li4, Mark M. Goodman1, Jonathon A Nye1, David M. Schuster1. Author affiliations: 1. Radiology and Imaging Sciences, Emory University, Atlanta, GA, USA 2. Surgery, Emory University, Atlanta, GA, USA 3. Radiology, Loyola University Medical Center, Maywood, Illinois, USA 4. Pathology and Laboratory Medicine, Emory University, Atlanta, GA, USA Corresponding Author: David M. Schuster, MD; Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University Hospital, 1364 Clifton Road, Atlanta, GA 30322. Telephone: 404-712-4859, Fax: 404-712-4860, email: [email protected] First Author: Funmilayo Tade, MD, MPH; Research Fellow, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University Hospital, 1364 Clifton Road, Atlanta, GA 30322. Telephone: 404-712-1348, Fax: 404-712-4860, email: [email protected] Word Count: 4,946 Grant Sponsor: Glenn Family Breast Center Grant; Winship Cancer Institute, Emory University. FLUCICLOVINE PET-CT IN BREAST CANCER The purpose of this study is to explore the uptake of the synthetic amino acid analog positron emission tomography (PET) radiotracer anti-3-[18F] FACBC (fluciclovine) in breast lesions with correlation to histologic and immunohistochemical characteristics. Methods Twelve women with breast lesions underwent 45 minute dynamic PET-CT of the thorax after intravenous administration of 366.3 ±14.8 (337.44 - 394.05) MBq of fluciclovine. -
ACMUI Chairman, Presiding
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Meeting of the Advisory Committee on the Medical Uses of Isotopes Docket Number: (n/a) Location: Teleconference Date: Monday, March 30, 2020 Work Order No.: NRC-0868 Pages 1-262 NEAL R. GROSS AND CO., INC. Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION + + + + + ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES + + + + + TELECONFERENCE + + + + + MONDAY, MARCH 30, 2020 + + + + + The meeting was convened by teleconference, at 9:30 a.m., Dr. Darlene F. Metter, ACMUI Chairman, presiding. MEMBERS PRESENT: DARLENE F. METTER, M.D., Chairman A. ROBERT SCHLEIPMAN, Ph.D., Vice Chairman GARY BLOOM, Member VASKEN DILSIZIAN, M.D., Member RONALD D. ENNIS, M.D., Member RICHARD L. GREEN, Member HOSSEIN JADVAR, Member MELISSA C. MARTIN, Member MICHAEL D. O'HARA, Ph.D., Member ZOUBIR OUHIB, Member NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 2 MICHAEL SHEETZ, Member MEGAN L. SHOBER, Member HARVEY B. WOLKOV, M.D., Member DESIGNATED FEDERAL OFFICERS: CHRISTIAN EINBERG, Chief, Medical Safety and Events Assessment Branch (MSEB) LISA DIMMICK, Medical Radiation Safety Team Leader, NMSS/MSST/MSEB KELLEE JAMERSON, ACMUI Coordinator NRC STAFF PRESENT: KEVIN WILLIAMS, Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST) MARYANN AYOADE, NMSS/MSST/MSEB SAID DAIBES, Ph.D., NMSS/MSST/MSEB DANIEL DIMARCO, NMSS/MSST/MSEB JASON DRAPER, NMSS/MSST/MSEB ROBIN ELLIOTT, NMSS/MSST/MSEB JENNIFER FISHER, NMSS/MSST/MSEB SARA FORSTER, NMSS/MSST/MSEB ROBERT GALLAGHAR, R-I/DNMS/MLAB ANITA GRAY, Ph.D., NMSS/MSST/SMPB VINCENT HOLAHAN, NMSS/MSST NEAL R. -
Download Final Programme As
LETTER OF INVITATION LETTER OF INVITATION WELCOME WORDS by the EANM Congress Chair EANM’20 EANM’20 On behalf of the European Association of Nuclear Medicine, it is my great honour to invite you to the 33rd Annual EANM WORLD LEADING MEETING LEADING WORLD Congress, which will take place virtually from 22 to 30 MEETING LEADING WORLD October 2020. Nuclear Medicine keeps on growing in many number of newer features are also being planned clinical areas, from diagnostic imaging to and we will have a new format for the plenary therapy: our procedures are increasingly being sessions, new top-rated oral presentation sessions incorporated into clinical practice, in a variety of and a new ‘Top Trials’ session. settings and diseases. This success is mostly related to a peculiar characteristic of our specialty, namely A further characteristic of our Congress is its the functional approach to medicine. PET imaging multidisciplinarity, and this will be emphasised works so well because of the unique functional in 2020, with a number of sessions bringing information provided to clinicians, and this feature together physicians from many specialties as well is the key to the ongoing rapid diffusion of Nuclear as specialists in radiochemistry and pharmacy, Medicine. physicists and other professionals. In addition, a dedicated track for technologists will be provided. In recent years, the status of the EANM Congress as the world-leading meeting in Nuclear Medicine If all of this still isn’t enough to motivate you to has been firmly established. The number of attend the EANM’20 Congress virtually, we are attendees in 2019 exceeded that in any previous working on providing some extra entertainment to year, with more than 6950 participants, but we make your virtual experience even more fun. -
Tauvid Integrated Review Document
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 212123Orig1s000 INTEGRATED REVIEW Executive Summary Interdisciplinary Assessment Appendices NDA212123 Tauvid (flortaucipir F 18 injection) Integrated Review Table 1. Administrative Application Information Category Application Information Application type NDA Application number{s) 212123 Priority or standard Ptiority Submit date{s) 9/30/2019 Received date(s) 9/30/2019 PDUFA goal date 5/29/2020 Division/office Division oflmaging and Radiation Medicine (DIRM) Review completion date 5/27/2020 Established name Flo1taucipir F 18 (Proposed) trade name Tauvid Pharmacologic class Radioactive diagnostic agent (for PET imaging) Code name F18-AV-1451 , F18-T807, LSN3182568 Applicant Avid Radiopha1maceuticals Inc Dose form/formulation(s) Injection Dosing regimen 370 MBq (10 mCi), administered as a bolus intravenous injection Applicant proposed For positron emission tomography (PET) imaging ofthe brain to indication{s)/population{s) estimate the density and disttibution of ag~gated tau 4 nemofibrillary tangles (NFTs) !b>T m adult oatients who are bein~evaluat~d for AD (b)(4__<l>H_ •l Proposed SNOMED indication Regulatory action Approval Approved Tauvid is indicated for use with PET imaging of the brain to indication{s)/population{s) estimate the density and disttibution of aggregated tau NFTs in {if applicable) adult patients with cognitive impaiiment who are being evaluated for AD. Limitations ofUse: Tauvid is not indicated for use in the evaluation ofpatients for chronic traumatic encephalopathy (CTE) Approved SNOMED 386806002 Ihnpaired cognition (fmdiI1g) indication Integrated Review Template, version date 2019/09/25 Reference ID: 4615642 NDA212123 Tauvid (flortaucipir F 18 injection) Table of Contents Table ofTables ....................................................................................................................v Table ofFigures ............................................................................................................... -
Neuroimaging of Alzheimer's Disease: Focus on Amyloid and Tau
Japanese Journal of Radiology (2019) 37:735–749 https://doi.org/10.1007/s11604-019-00867-7 INVITED REVIEW Neuroimaging of Alzheimer’s disease: focus on amyloid and tau PET Hiroshi Matsuda1 · Yoko Shigemoto2 · Noriko Sato2 Received: 23 July 2019 / Accepted: 28 August 2019 / Published online: 6 September 2019 © Japan Radiological Society 2019 Abstract Although the diagnosis of dementia is still largely a clinical one, based on history and disease course, neuroimaging has dra- matically increased our ability to accurately diagnose it. Neuroimaging modalities now play a wider role in dementia beyond their traditional role of excluding neurosurgical lesions and are recommended in most clinical guidelines for dementia. In addition, new neuroimaging methods facilitate the diagnosis of most neurodegenerative conditions after symptom onset and show diagnostic promise even in the very early or presymptomatic phases of some diseases. In the case of Alzheimer’s disease (AD), extracellular amyloid-β (Aβ) aggregates and intracellular tau neurofbrillary tangles are the two neuropathological hallmarks of the disease. Recent molecular imaging techniques using amyloid and tau PET ligands have led to preclinical diagnosis and improved diferential diagnosis as well as narrowed subject selection and treatment monitoring in clinical trials aimed at delaying or preventing the symptomatic phase of AD. This review discusses the recent progress in amyloid and tau PET imaging and the key fndings achieved by the use of this molecular imaging modality related to the respective roles of Aβ and tau in AD, as well as its specifc limitations. Keywords Dementia · Alzheimer’s disease · PET · Amyloid · Tau Introduction expected to reach 7 million in 2025, representing approxi- mately one in fve elderly people in Japan [3]. -
Mars Shot for Nuclear Medicine, Molecular Imaging, and Molecularly Targeted Radiopharmaceutical Therapy
THE STATE OF THE ART Mars Shot for Nuclear Medicine, Molecular Imaging, and Molecularly Targeted Radiopharmaceutical Therapy Richard L. Wahl1, Panithaya Chareonthaitawee2, Bonnie Clarke3, Alexander Drzezga4, Liza Lindenberg5, Arman Rahmim6, James Thackeray7, Gary A. Ulaner8, Wolfgang Weber9, Katherine Zukotynski10, and John Sunderland11 1Mallinckrodt Institute of Radiology, Washington University St. Louis, Missouri; 2Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; 3Research and Discovery, Society of Nuclear Medicine and Molecular Imaging, Reston, Virginia; 4Department of Nuclear Medicine, University of Cologne, Cologne, Germany, German Center for Neurodegenerative Diseases, Bonn- Cologne, Germany, and Institute of Neuroscience and Medicine, Molecular Organization of the Brain, Forschungszentrum J¨ulich, J¨ulich, Germany; 5Molecular Imaging Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland; 6Departments of Radiology and Physics, University of British Columbia, Vancouver, British Columbia, Canada; Department of Integrative Oncology, BC Cancer Research Institute, Vancouver, British Columbia, Canada; 7Department of Nuclear Medicine, Hannover Medical School, Hannover, Germany; 8Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, and Molecular Imaging and Therapy, Hoag Cancer Center, Newport Beach, California; 9Department of Nuclear Medicine, Technical University Munich, Munich, Germany; 10Departments of Medicine and Radiology, -
Fluorine-18 Labeled Amino Acids for Tumor PET/CT Imaging
www.impactjournals.com/oncotarget/ Oncotarget, 2017, Vol. 8, (No. 36), pp: 60581-60588 Review Fluorine-18 labeled amino acids for tumor PET/CT imaging Yiqiang Qi1,2,*, Xiaohui Liu1,2,*, Jun Li4, Huiqian Yao5 and Shuanghu Yuan2,3 1School of Medicine and Life Sciences, University of Jinan-Shandong Academy of Medical Sciences, Jinan, Shandong, China 2Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong Cancer Hospital affiliated to Shandong University, Jinan, Shandong, China 3Shandong Academy of Medical Sciences, Jinan, Shandong, China 4Department of Thoracic Surgery, Shandong Provincial Hospital, Jinan, Shandong, China 5Department of Surgery, Juye Coalfield Central Hospital, Heze, Shandong, China *Authors contributed equally to this work Correspondence to: Shuanghu Yuan, email: [email protected] Keywords: Fluorine-18 labeled amino acids, positron emission tomography/computed tomography (PET/CT), tumor metabolism, molecular imaging Received: May 25, 2017 Accepted: July 25, 2017 Published: August 04, 2017 Copyright: Qi et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License 3.0 (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. ABSTRACT Tumor glucose metabolism and amino acid metabolism are usually enhanced, 18F-FDG for tumor glucose metabolism PET imaging has been clinically well known, but tumor amino acid metabolism PET imaging is not clinically familiar. Radiolabeled amino acids (AAs) are an important class of PET/CT tracers that target the upregulated amino acid transporters to show elevated amino acid metabolism in tumor cells. Radiolabeled amino acids were observed to have high uptake in tumor cells but low in normal tissues and inflammatory tissues. -
Oncologic Applications of Positron Emission Tomography Scanning
FEP 6.01.26 Oncologic Applications of Positron Emission Tomography Scanning FEP Medical Policy Manual FEP 6.01.26 Oncologic Applications of Positron Emission Tomography Scanning Related Policies: Effective Policy Date: January 1, 2021 6.01.06 - Miscellaneous (Noncardiac, Nononcologic) Applications of Fluorine 18 Fluorodeoxyglucose Positron Emission Tomography Original Policy Date: June 2012 6.01.20 - Cardiac Applications of Positron Emission Tomography Scanning 6.01.51 - Interim Positron Emission Tomography Scanning in Oncology to Detect Early Response During Treatment Oncologic Applications of Positron Emission Tomography Scanning Description Positron emission tomography (PET) scans are based on the use of positron-emitting radionuclide tracers coupled to organic molecules, such as glucose, ammonia, or water. The radionuclide tracers simultaneously emit 2 high-energy photons in opposite directions that can be simultaneously detected (referred to as coincidence detection) by a PET scanner, comprising multiple stationary detectors that encircle the area of interest. A variety of tracers are used for positron emission tomography (PET) scanning, including oxygen 15, nitrogen 13, carbon 11 choline, fluorine 18, gallium 68, and fluciclovine 18. Because of their short half-life, some tracers must be made locally using an onsite cyclotron. The radiotracer most commonly used in oncology imaging has been fluorine 18 coupled with fluorodeoxyglucose (FDG), which correlates with glucose metabolism. Fluorodeoxyglucose has been considered useful in cancer imaging because tumor cells show increased metabolism of glucose. The most common malignancies studied have been melanoma, lymphoma, lung, colorectal, and pancreatic cancer. This evidence review focuses on the use of radiotracers detected with dedicated PET scanners. Radiotracers, such as FDG, may be detected using single-photon emission computerized tomography cameras, a technique that may be referred to as FDG-single-photon emission computerized tomography imaging.