Itap Managed Care Working Group Task Team 1: Chronic
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PET Imaging of Occult Tumours by Temporal Integration of Tumour-Acidosis Signals from Ph-Sensitive 64Cu-Labelled Polymers
ARTICLES https://doi.org/10.1038/s41551-019-0416-1 PET imaging of occult tumours by temporal integration of tumour-acidosis signals from pH-sensitive 64Cu-labelled polymers Gang Huang 1, Tian Zhao1, Chensu Wang 1, Kien Nham2, Yahong Xiong2, Xiaofei Gao3, Yihui Wang3, Guiyang Hao 2, Woo-Ping Ge3, Xiankai Sun2, Baran D. Sumer 4* and Jinming Gao 1,4* Owing to the diversity of cancer types and the spatiotemporal heterogeneity of tumour signals, high-resolution imaging of occult malignancy is challenging. 18F-fluorodeoxyglucose positron emission tomography allows for near-universal cancer detec- tion, yet in many clinical scenarios it is hampered by false positives. Here, we report a method for the amplification of imaging contrast in tumours via the temporal integration of the imaging signals triggered by tumour acidosis. This method exploits the catastrophic disassembly, at the acidic pH of the tumour milieu, of pH-sensitive positron-emitting neutral copolymer micelles into polycationic polymers, which are then internalized and retained by the cancer cells. Positron emission tomography imaging of the 64Cu-labelled polymers detected small occult tumours (10–20 mm3) in the brain, head, neck and breast of mice at much higher contrast than 18F-fluorodeoxyglucose, 11C-methionine and pH-insensitive 64Cu-labelled nanoparticles. We also show that the pH-sensitive probes reduce false positive detection rates in a mouse model of non-cancerous lipopolysaccharide-induced inflammation. This macromolecular strategy for integrating tumour acidosis should enable improved cancer detection, surveil- lance and staging. ancer exhibits diverse genetic and histological differences tumours over the surrounding normal tissues often leads to false from normal tissues1. -
Assessment of Cardiac Amyloidosis with 99MTC- Pyrophosphate (PYP) Quantitative Spect
Assessment of Cardiac Amyloidosis With 99MTC- pyrophosphate (PYP) Quantitative Spect Chao Ren Peking Union Medical College Hospital Jingyun Ren Peking Union Medical College Hospital Zhuang Tian Peking Union Medical College Hospital Yanrong Du Peking Union Medical College Hospital Zhixin Hao Peking Union Medical College Hospital Zongyao Zhang Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital Wei Fang Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital Fang Li Peking Union Medical College Hospital Shuyang Zhang Peking Union Medical College Hospital Bailing Hsu University of Missouri-Columbia Li Huo ( [email protected] ) Peking Union Medical College Hospital https://orcid.org/0000-0003-1216-083X Original research Keywords: ATTR cardiomyopathy, 99mTc-PYP quantitative SPECT, standardized uptake value, diagnostic feasibility, the operator reproducibility Posted Date: June 5th, 2020 DOI: https://doi.org/10.21203/rs.3.rs-32649/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/25 Version of Record: A version of this preprint was published on January 7th, 2021. See the published version at https://doi.org/10.1186/s40658-020-00342-7. Page 2/25 Abstract Background: 99mTc-PYP scintigraphy provides differential diagnosis of ATTR cardiomyopathy (ATTR-CM) from lightchain cardiac amyloidosis and other myocardial disorders without biopsy. This study was aimed to assess the diagnostic feasibility and the operator reproducibility of 99mTc-PYP quantitative SPECT. Method:Thirty-seven consecutive patients underwent a99mTc-PYP thorax planar scan followed by SPECT and CT scans to diagnose suspected ATTR-CM were enrolled. For the quantitative SPECT, phantom studies were initially performed to determine the image conversion factor (ICF) and partial volume correction (PVC) factor to recover 99mTc-PYP activity concentration in myocardium for calculating the standardized uptake value (SUV) (unit: g/ml). -
Nuclear Medicine for Medical Students and Junior Doctors
NUCLEAR MEDICINE FOR MEDICAL STUDENTS AND JUNIOR DOCTORS Dr JOHN W FRANK M.Sc, FRCP, FRCR, FBIR PAST PRESIDENT, BRITISH NUCLEAR MEDICINE SOCIETY DEPARTMENT OF NUCLEAR MEDICINE, 1ST MEDICAL FACULTY, CHARLES UNIVERSITY, PRAGUE 2009 [1] ACKNOWLEDGEMENTS I would very much like to thank Prof Martin Šámal, Head of Department, for proposing this project, and the following colleagues for generously providing images and illustrations. Dr Sally Barrington, Dept of Nuclear Medicine, St Thomas’s Hospital, London Professor Otakar Bělohlávek, PET Centre, Na Homolce Hospital, Prague Dr Gary Cook, Dept of Nuclear Medicine, Royal Marsden Hospital, London Professor Greg Daniel, formerly at Dept of Veterinary Medicine, University of Tennessee, currently at Virginia Polytechnic Institute and State University (Virginia Tech), Past President, American College of Veterinary Radiology Dr Andrew Hilson, Dept of Nuclear Medicine, Royal Free Hospital, London, Past President, British Nuclear Medicine Society Dr Iva Kantorová, PET Centre, Na Homolce Hospital, Prague Dr Paul Kemp, Dept of Nuclear Medicine, Southampton University Hospital Dr Jozef Kubinyi, Institute of Nuclear Medicine, 1st Medical Faculty, Charles University Dr Tom Nunan, Dept of Nuclear Medicine, St Thomas’s Hospital, London Dr Kathelijne Peremans, Dept of Veterinary Medicine, University of Ghent Dr Teresa Szyszko, Dept of Nuclear Medicine, St Thomas’s Hospital, London Ms Wendy Wallis, Dept of Nuclear Medicine, Charing Cross Hospital, London Copyright notice The complete text and illustrations are copyright to the author, and this will be strictly enforced. Students, both undergraduate and postgraduate, may print one copy only for personal use. Any quotations from the text must be fully acknowledged. It is forbidden to incorporate any of the illustrations or diagrams into any other work, whether printed, electronic or for oral presentation. -
A Technique for Standardized Central Analysis of 6-18F-Fluoro-L-DOPA PET Data from a Multicenter Study
A Technique for Standardized Central Analysis of 6-18F-Fluoro-L-DOPA PET Data from a Multicenter Study Alan L. Whone, MRCP1; Dale L. Bailey, PhD2; Philippe Remy, PhD3; Nicola Pavese, MD1; and David J. Brooks, DSc1 1Division of Neuroscience and MRC Clinical Sciences Centre, Faculty of Medicine, Imperial College, Hammersmith Hospital, London, United Kingdom; 2Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, Australia; and 3CEA-Centre National de la Recherche Scientifique Unite´ de Recherche Associe´e 2210, Service Hospitalier Frederic Joliot, Orsay, France tralized analysis offers the potential for improved detection of We have recently completed a large 6-18F-fluoro-L-DOPA (18F- outcomes due to the standardization of the analytic approach DOPA) PET study comparing rates of loss of dopamine terminal and allows the analysis of large numbers of PET studies. function in Parkinson’s disease (PD) patients taking either the Key Words: PET; 18F-DOPA; Parkinson’s disease; progression; dopamine agonist ropinirole or L-DOPA. This trial involved a central analysis “distributed acquisition/centralized analysis” method, in which J Nucl Med 2004; 45:1135–1145 18F-DOPA images were acquired at 6 different PET centers around the world and then analyzed at a single site. To our knowledge, this is the first time such a centralized approach has been employed with 18F-DOPA PET and this descriptive basic science article outlines the methods used. Methods: One hun- With rapid advances in molecular medicine, the pro- dred eighty-six PD patients were randomized (1:1) to ropinirole duction of neuroprotective or neurorestorative agents that or L-DOPA therapy, and 18F-DOPA PET was performed at base- affect the progression of degenerative conditions such as line and again at 2 y. -
[123I]FP-CIT SPECT in Atypical Degenerative Parkinsonism
CONTRAST AGENT EVALUATION [123I]FP-CIT SPECT in atypical degenerative parkinsonism One of the most widely used techniques to support the clinical diagnosis of Parkinson’s disease is the SPECT scan with [123I]FP-CIT. This tracer binds reversibly and visualizes the striatal presynaptic dopamine transporters. Several uncertainties remain on the value of [123I]FP-CIT and SPECT in atypical degenerative parkinsonian syndromes. In this concise review, we discuss the contribution of SPECT and [123I]FP-CIT in supporting the clinical diagnosis of Parkinson’s disease and their role in the differential diagnosis of Parkinson’s disease and atypical degenerative parkinsonism. The chemistry, pharmacodynamics and pharmacokinetics of [123I]FP-CIT are also discussed. 1,2,3 KEywordS: atypical degenerative parkinsonism n FP-CIT n ioflupane n SPECT Ioannis U Isaias* , Giorgio Marotta4, Gianni Pezzoli2, Parkinson’s disease (PD) is the second most dystonic tremor [15] and psychogenic parkin- Osama Sabri5 [1] [16,17] 5,6 common neurodegenerative disorder , yet sonism . In this concise review, we will & Swen Hesse 123 early accurate diagnosis remains challenging. discuss the role of SPECT and [ I]FP-CIT in 1Università degli Studi di Milano, The estimated prevalence of PD is 0.5–1% in supporting the clinical diagnosis of PD and its Dipartimento di Fisiologia Umana, those aged 65–69 years and 1–3% in those aged differential diagnosis with ADP. Milano, Italy 2Centro per la Malattia di Parkinson e i ≥80 years [1]. Although the clinical diagnosis of Disturbi del Movimento, -
USAN Naming Guidelines for Monoclonal Antibodies |
Monoclonal Antibodies In October 2008, the International Nonproprietary Name (INN) Working Group Meeting on Nomenclature for Monoclonal Antibodies (mAb) met to review and streamline the monoclonal antibody nomenclature scheme. Based on the group's recommendations and further discussions, the INN Experts published changes to the monoclonal antibody nomenclature scheme. In 2011, the INN Experts published an updated "International Nonproprietary Names (INN) for Biological and Biotechnological Substances—A Review" (PDF) with revisions to the monoclonal antibody nomenclature scheme language. The USAN Council has modified its own scheme to facilitate international harmonization. This page outlines the updated scheme and supersedes previous schemes. It also explains policies regarding post-translational modifications and the use of 2-word names. The council has no plans to retroactively change names already coined. They believe that changing names of monoclonal antibodies would confuse physicians, other health care professionals and patients. Manufacturers should be aware that nomenclature practices are continually evolving. Consequently, further updates may occur any time the council believes changes are necessary. Changes to the monoclonal antibody nomenclature scheme, however, should be carefully considered and implemented only when necessary. Elements of a Name The suffix "-mab" is used for monoclonal antibodies, antibody fragments and radiolabeled antibodies. For polyclonal mixtures of antibodies, "-pab" is used. The -pab suffix applies to polyclonal pools of recombinant monoclonal antibodies, as opposed to polyclonal antibody preparations isolated from blood. It differentiates polyclonal antibodies from individual monoclonal antibodies named with -mab. Sequence of Stems and Infixes The order for combining the key elements of a monoclonal antibody name is as follows: 1. -
(19) United States (12) Patent Application Publication (10) Pub
US 20130289061A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0289061 A1 Bhide et al. (43) Pub. Date: Oct. 31, 2013 (54) METHODS AND COMPOSITIONS TO Publication Classi?cation PREVENT ADDICTION (51) Int. Cl. (71) Applicant: The General Hospital Corporation, A61K 31/485 (2006-01) Boston’ MA (Us) A61K 31/4458 (2006.01) (52) U.S. Cl. (72) Inventors: Pradeep G. Bhide; Peabody, MA (US); CPC """"" " A61K31/485 (201301); ‘4161223011? Jmm‘“ Zhu’ Ansm’ MA. (Us); USPC ......... .. 514/282; 514/317; 514/654; 514/618; Thomas J. Spencer; Carhsle; MA (US); 514/279 Joseph Biederman; Brookline; MA (Us) (57) ABSTRACT Disclosed herein is a method of reducing or preventing the development of aversion to a CNS stimulant in a subject (21) App1_ NO_; 13/924,815 comprising; administering a therapeutic amount of the neu rological stimulant and administering an antagonist of the kappa opioid receptor; to thereby reduce or prevent the devel - . opment of aversion to the CNS stimulant in the subject. Also (22) Flled' Jun‘ 24’ 2013 disclosed is a method of reducing or preventing the develop ment of addiction to a CNS stimulant in a subj ect; comprising; _ _ administering the CNS stimulant and administering a mu Related U‘s‘ Apphcatlon Data opioid receptor antagonist to thereby reduce or prevent the (63) Continuation of application NO 13/389,959, ?led on development of addiction to the CNS stimulant in the subject. Apt 27’ 2012’ ?led as application NO_ PCT/US2010/ Also disclosed are pharmaceutical compositions comprising 045486 on Aug' 13 2010' a central nervous system stimulant and an opioid receptor ’ antagonist. -
Monoclonal Antibody Playbook
Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide Outpatient administration guide for healthcare providers 2 SEPTEMBER 2021 1 Introduction to COVID-19 Monoclonal Antibody Therapy 2 Overview of Emergency Use Authorizations 3 Site and Patient Logistics Site preparation Patient pathways to monoclonal administration 4 Team Roles and Responsibilities Leadership Administrative Clinical Table of 5 Monoclonal Antibody Indications and Administration Indications Contents Preparation Administration Response to adverse events 6 Supplies and Resources Infrastructure Administrative Patient Intake Administration 7 Examples: Sites of Administration and Staffing Patterns 8 Additional Resources 1 1. Introduction to Monoclonal Therapy 2 As of 08/13/21 Summary of COVID-19 Therapeutics 1 • No Illness . Health, no infections • Exposed Asymptomatic Infected . Scope of this Implementation Guide . Not hospitalized, no limitations . Monoclonal Antibodies for post-exposure prophylaxis (Casirivimab + Imdevimab (RGN)) – EUA Issued. • Early Symptomatic . Scope of this Implementation Guide . Not hospitalized, with limitations . Monoclonal Antibodies for treatment (EUA issued): Bamlanivimab + Etesevimab1 (Lilly) Casirivimab + Imdevimab (RGN) Sotrovimab (GSK/Vir) • Hospital Adminission. Treated with Remdesivir (FDA Approved) or Tocilizumab (EUA Issued) . Hospitalized, no acute medical problems . Hospitalized, not on oxygen . Hospitlaized, on oxygen • ICU Admission . Hospitalized, high flow oxygen, non-invasive ventilation -
DICOM Conformance Template
g GE Heathcare Technical Publications Direction 5507068-1EN (DOC1584283) Revision 1 DaTQUANT Application™ DICOM CONFORMANCE STATEMENT Copyright 2015 by General Electric Co. Do not duplicate g GE Heathcare LIST OF REVISIONS REV DATE DESCRIPTION PAGES APPR. 1 May 2015 Initial Release All M. Mesh DATQUANT APPLICATION GE Healthcare DICOM CONFORMANCE STATEMENT DIR 5507068-1EN (DOC1584283) REV 1 THIS PAGE LEFT INTENTIONALLY BLANK DATQUANT APPLICATION GE Healthcare DICOM CONFORMANCE STATEMENT DIR 5507068-1EN (DOC1584283) REV 1 CONFORMANCE STATEMENT OVERVIEW DaTQUANT application is an application that uses NM and CT images and creates NM, SC and MFSC images. Table 0.1 provides an overview of the network services supported by the DaTQUANT application. Table 0.1 – APPLICATION SOP Classes User of Object Creator of Instances Object Instances Transfer Secondary Capture Image Storage No Yes Multi-frame True Color Secondary Capture Image Storage No Yes Nuclear Medicine Image Storage Yes Yes Computerized Tomography Image Storage Yes No 4 DATQUANT APPLICATION GE Healthcare DICOM CONFORMANCE STATEMENT DIR 5507068-1EN (DOC1584283) REV 1 1. INTRODUCTION ............................................................................................................... 8 1.1 Overview ..................................................................................................................................................................... 8 1.2 Overall DICOM Conformance Statement Document Structure .......................................................................... -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
REGENERON PHARMACEUTICALS, INC. (Exact Name of Registrant As Specified in Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 9, 2017 (February 9, 2017) REGENERON PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in Charter) New York 000-19034 13-3444607 (State or other jurisdiction (Commission (IRS Employer of Incorporation) File No.) Identification No.) 777 Old Saw Mill River Road, Tarrytown, New York 10591-6707 (Address of principal executive offices, including zip code) (914) 847-7000 (Registrant's telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 2.02 Results of Operations and Financial Condition. On February 9, 2017, Regeneron Pharmaceuticals, Inc. issued a press release announcing its financial and operating results for the quarter and year ended December 31, 2016. A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 2.02. -
Orange Book Cumulative Supplement 6 June 2011
CUMULATIVE SUPPLEMENT 6 June 2011 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 31st EDITION Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Generic Drugs 2011 Prepared By Office of Generic Drugs Center for Drug Evaluation and Research Food and Drug Administration APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 31st EDITION Cumulative Supplement 6 June 2011 CONTENTS PAGE 1.0 INTRODUCTION ........................................................................................................................................ iii 1.1 How to use the Cumulative Supplement ........................................................................................... iii 1.2 Cumulative Supplement Content....................................................................................................... iv 1.3 Applicant Name Changes................................................................................................................... v 1.4 Levothyroxine Sodium........................................................................................................................ v 1.5 Availability of the Edition ................................................................................................................... vi 1.6 Report of Counts for the Prescription Drug Product List .................................................................. vii 1.7 Cumulative Supplement Legend ......................................................................................................viii