WHO List of Priority Medical Devices for Cancer Management
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Landscape Analysis of Phase 2/3 Clinical Trials of Targeted
Journal of Nuclear Medicine, published on February 12, 2021 as doi:10.2967/jnumed.120.258103 Landscape analysis of Phase 2/3 clinical trials for Targeted Radionuclide Therapy Erik Mittra1, Amanda Abbott2, and Lisa Bodei3 Affiliations 1. Division of Nuclear Medicine & Molecular Imaging, Oregon Health & Science University, Portland, OR 2. Clinical Trials Network, Society of Nuclear Medicine & Molecular Imaging, Reston, VA 3. Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY Word count without figure: 880 Word count with figure: 971 Key Words: radioisotope therapy, radiopharmaceutical therapy and radioligand therapy Text Within Nuclear Medicine, theranostics has revitalized the field of Targeted Radionuclide Therapy (TRT) and there is a growing number of investigator-initiated and industry-sponsored clinical trials of TRT. This article summarizes the current trials available in the NIH database, the largest trial repository, to provide both an overview of the current landscape and a glimpse towards an undeniably exciting future of theranostics. This landscape analysis was completed by searching the terms “radionuclide therapy”, “radioisotope therapy”, “radiopharmaceutical therapy” and “radioligand therapy” on ClinicalTrials.gov in November 2020. Other terms may provide different results. Phase 1/2, 2, and 3 trials that are currently recruiting and those not yet recruiting were included. Studies. Overall, the results showed 42 clinical trials including 13 Phase 1/2, 26 Phase 2, and three Phase 3. Given this range of phases, the planned enrollment varies widely from 10-813, with an average of 147 participants. Five different radioisotopes, 12 ligands or targets, and 11 different cancer types are represented (Figure 1). -
PPE Requirements Hazardous Drug Handling
This document’s purpose is only to provide general guidance. It is not a definitive interpretation for how to comply with DOSH requirements. Consult the actual NIOSH hazardous drugs list and program regulations in entirety to understand all specific compliance requirements. Minimum PPE Required Minimum PPE Required Universal (Green) - handling and disposed of using normal precautions. PPE Requirements High (Red) - double gloves, gown, eye and face protection in Low (Yellow) - handle at all times with gloves and appropriate engineering Hazardous Drug Handling addition to any necessary controls. engineering controls. Moderate (Orange) -handle at all times with gloves, gown, eye and face protection (with splash potential) and appropirate engineering controls. Tablet Open Capsule Handling only - Contained Crush/Split No alteration Crush/Split Dispensed/Common Drug Name Other Drug Name Additional Information (Formulation) and (NIOSH CATEGORY #) Minimum PPE Minimum PPE Minimum PPE Minimum PPE Required required required required abacavir (susp) (2) ziagen/epzicom/trizivir Low abacavir (tablet) (2) ziagen/epzicom/trizivir Universal Low Moderate acitretin (capsule) (3) soriatane Universal Moderate anastrazole (tablet) (1) arimidex Low Moderate High android (capsule) (3) methyltestosterone Universal Moderate apomorphine (inj sq) (2) apomorphine Moderate arthotec/cytotec (tablet) (3) diclofenac/misoprostol Universal Low Moderate astagraf XL (capsule) (2) tacrolimus Universal do not open avordart (capsule) (3) dutasteride Universal Moderate azathioprine -
Handling of Hazardous Drugs Risk Prevention by Personal Protective Equipment Handling of Hazardous Drugs
HANDLING OF HAZARDOUS DRUGS RISK PREVENTION BY PERSONAL PROTECTIVE EQUIPMENT HANDLING OF HAZARDOUS DRUGS INTRODUCTION CONTENT The expression “antineoplastic drug” (ANPD) is often used synonymously together with “cytostatics” or Introduction 2 “chemotherapeutics”, however, these terms normally Definition of Risks 4 describe an overarching category to which other drug- classes belong. These types of drugs belong to drug- Causes for Risks 10 specialties summarized under the term “Hazardous Consequences 14 Drugs”, according to the CDC’s (Centers for Disease Control and Prevention) NIOSH4 alert in 2004. The Preventive Strategies 16 term ANPD describes in general the activity of these Risk Prevention 26 drugs against a neoplasm, characterizing an abnormal growth of tissue. In a recent systematic review and Literature 28 meta-analysis of the literature5 the expression “ANPD” Mandatory Information 31 is used in a general manner, therefore it is applied in this review, too. INTRODUCTION Antineoplastic drugs (ANPD) have been introduced ANPDs represent a broad and non-homogenous group for cancer treatment since the 1940s. More than of chemicals with a variety of structures, origins, ac- 12 million patients are treated with ANPDs each tivities and effects at the cellular level. They are cate- year. Nowadays the number of cancer diagnoses gorized according to their specific potential of toxicity is continuously increasing. or to their mechanisms of action, described in more detail in the chapter “Definition of risks”. Currently, the This brochure addresses the hazardous effects of anti- list encompassing ANPDs used in daily clinical practice neoplastic drugs, the importance of risk assessment contains more than 115 special drugs1. and standard precautions of personal protection as recommended by the 2004-NIOSH (National Institute During the 1970’s first concerns with respect to toxic for Occupational Safety and Health)-Alert and corre- side effects were raised further to cases that had been 1, 2, 3 sponding updates in 2010 / 2012 and 2016. -
Understanding Icd-10-Cm and Icd-10-Pcs 3Rd Edition Download Free
UNDERSTANDING ICD-10-CM AND ICD-10-PCS 3RD EDITION DOWNLOAD FREE Mary Jo Bowie | 9781305446410 | | | | | International Classification of Diseases, (ICD-10-CM/PCS) Transition - Background Palmer B. Manual placenta removal. A: Understanding ICD-10-CM and ICD-10-PCS 3rd edition International Classification of Diseases ICD is a common framework and language to report, compile, use and compare health information. Psychoanalysis Adlerian therapy Analytical therapy Mentalization-based treatment Transference focused psychotherapy. Hysteroscopy Vacuum aspiration. Every code begins with an alpha character, which is indicative of the chapter to which the code is classified. Search Compliance Understanding BC, resilience standards and how to comply Follow these nine steps to first identify relevant business continuity and resilience standards and, second, launch a successful While many coders use ICD lookup software to help them, referring to an ICD code book is invaluable to build an understanding of the classification system. Pregnancy test Leopold's maneuvers Prenatal testing. Endoscopy : Colonoscopy Anoscopy Capsule endoscopy Enteroscopy Proctoscopy Sigmoidoscopy Abdominal ultrasonography Defecography Double-contrast barium enema Endoanal ultrasound Enteroclysis Lower gastrointestinal series Small-bowel follow-through Transrectal ultrasonography Virtual colonoscopy. Psychosurgery Lobotomy Bilateral cingulotomy Multiple subpial transection Hemispherectomy Corpus callosotomy Anterior temporal lobectomy. While codes in sections are structured similarly to the Medical and Surgical section, there are a few exceptions. Send Feedback Do you have Understanding ICD-10-CM and ICD-10-PCS 3rd edition on the new website? Help Learn to edit Community portal Recent changes Upload file. D Radiation oncology. Stem cell transplantation Hematopoietic stem cell transplantation. The primary distinctions are:. Palmer Joseph C. -
RADIO PHARMACEUTICALS Production Control Safety Precautions Applications Storage
RADIO PHARMACEUTICALS Production control Safety precautions Applications Storage. Presented by: K. ARSHAD AHMED KHAN M.Pharm, (Ph.D) Department of Pharmaceutics, Raghavendra Institute of Pharmaceutical Education and Research [RIPER] Anantapur. 1 DEFINITION: Radiopharmaceuticals are the radioactive substances or radioactive drugs for diagnostic or therapeutic interventions. or Radiopharmaceuticals are medicinal formulations containing radioisotopes which are safe for administration in humans for diagnosis or for therapy. 2 COMPOSITION: • A radioactive isotope that can be injected safely into the body, and • A carrier molecule which delivers the isotope to the area to be treated or examined. 3 USAGE/WORKING: 4 BASICS Nuclide: This is a particular nuclear species characterized by its atomic number (No. of protons) and mass 12 23 number (No. of protons + neutrons). 6C , 11Na Isotopes: These are nuclides with same atomic number and different mass number. 1 2 3 Hydrogen has 3 isotopes --- 1H , 1H , 1H . 10 11 12 13 14 Carbon has 5 isotopes ------6C , 6C , 6C , 6C , 6C . 5 • ISOTOPES MAY BE STABLE OR UNSTABLE. • The nucleus is unstable if the number of neutrons is less or greater than the number of protons. • If they are unstable, they under go radioactive decay or disintegration and are known as radioactive isotopes/ radioactive nuclides. Radioactivity: The property of unstable nuclides of emitting radiation by spontaneous transformation of nuclei into other nuclides is called radioactivity. •Radioactive isotopes emit radiations or rays like α, β, γ rays. 6 PRODUCTION CONTROL 7 8 9 10 11 12 13 14 15 Radiopharmaceuticals production occurs in machines like 1. Cyclotron (low energy, high energy) 2. -
Characterization and Separation of Platinum-Based Antineoplastic
separations Article Characterization and Separation of Platinum-Based Antineoplastic Drugs by Zwitterionic Hydrophilic Interaction Liquid Chromatography (HILIC)–Tandem Mass Spectrometry, and Its Application in Surface Wipe Sampling Stefano Dugheri 1,* , Nicola Mucci 2 , Enrico Mini 3, Donato Squillaci 2 , Giorgio Marrubini 4 , Gianluca Bartolucci 5 , Elisabetta Bucaletti 2, Giovanni Cappelli 2, Lucia Trevisani 2 and Giulio Arcangeli 2 1 Industrial Hygiene and Toxicology Laboratory, Occupational Medicine Unit, Careggi University Hospital, 50134 Florence, Italy 2 Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy; nicola.mucci@unifi.it (N.M.); donato.squillaci@unifi.it (D.S.); elisabetta.bucaletti@unifi.it (E.B.); giovanni.cappelli@unifi.it (G.C.); lucia.trevisani@unifi.it (L.T.); giulio.arcangeli@unifi.it (G.A.) 3 Department of Health Sciences, University of Florence, 50134 Florence, Italy; enrico.mini@unifi.it 4 Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100 Pavia, Italy; [email protected] 5 Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, 50019 Sesto Fiorentino, Italy; gianluca.bartolucci@unifi.it Citation: Dugheri, S.; Mucci, N.; * Correspondence: stefano.dugheri@unifi.it Mini, E.; Squillaci, D.; Marrubini, G.; Bartolucci, G.; Bucaletti, E.; Cappelli, Abstract: Platinum-based antineoplastic drugs (PtADs) are among the most important and used G.; Trevisani, L.; Arcangeli, G. families of chemotherapy drugs, which, -
Understanding Surgery a Guide for People with Cancer, Their Families and Friends
Understanding Surgery A guide for people with cancer, their families and friends Treatment For information & support, call Understanding Surgery A guide for people with cancer, their families and friends First published April 2014. This edition April 2019. © Cancer Council Australia 2019. ISBN 978 1 925651 47 8 Understanding Surgery is reviewed approximately every three years. Check the publication date above to ensure this copy is up to date. Editor: Ruth Sheard. Designer: Eleonora Pelosi. Printer: SOS Print + Media Group. Acknowledgements This edition has been developed by Cancer Council NSW on behalf of all other state and territory Cancer Councils as part of a National Cancer Information Subcommittee initiative. We thank the reviewers of this booklet: Prof Andrew Spillane, Surgical Oncologist, Melanoma Institute of Australia, and Professor of Surgical Oncology, The University of Sydney Northern Clinical School, NSW; Lynne Hendrick, Consumer; Judy Holland, Physiotherapist, Calvary Mater Newcastle, NSW; Kara Hutchinson, Cancer Nurse Coordinator, St Vincent’s Hospital Melbourne, VIC; A/Prof Declan Murphy, Urologist and Director of Genitourinary Oncology, Peter MacCallum Cancer Centre, VIC; Caitriona Nienaber, 13 11 20 Consultant, Cancer Council WA; Prof Stephan Schug, Director of Pain Medicine, Royal Perth Hospital, and Chair of Anaesthesiology and Pain Medicine, The University of Western Australia Medical School, WA; Dr Emma Secomb, Specialist Surgeon, Hinterland Surgical Centre, QLD. We would like to thank the health professionals, consumers and editorial teams who have worked on previous editions of this title. This booklet is funded through the generosity of the people of Australia. Note to reader Always consult your doctor about matters that affect your health. -
Complex General Surgical Oncology
ACGME Program Requirements for Graduate Medical Education in Complex General Surgical Oncology ACGME-approved focused revision: February 3, 2020; effective July 1, 2020 Contents Introduction .............................................................................................................................. 3 Int.A. Preamble ................................................................................................................ 3 Int.B. Definition of Subspecialty ..................................................................................... 4 Int.C. Length of Educational Program ............................................................................ 4 I. Oversight ............................................................................................................................ 4 I.A. Sponsoring Institution............................................................................................ 4 I.B. Participating Sites .................................................................................................. 4 I.C. Recruitment ............................................................................................................. 6 I.D. Resources ............................................................................................................... 6 I.E. Other Learners and Other Care Providers ............................................................ 7 II. Personnel ........................................................................................................................... -
Targeted Radiotherapeutics from 'Bench-To-Bedside'
RadiochemistRy in switzeRland CHIMIA 2020, 74, No. 12 939 doi:10.2533/chimia.2020.939 Chimia 74 (2020) 939–945 © C. Müller, M. Béhé, S. Geistlich, N. P. van der Meulen, R. Schibli Targeted Radiotherapeutics from ‘Bench-to-Bedside’ Cristina Müllera, Martin Béhéa, Susanne Geistlicha, Nicholas P. van der Meulenab, and Roger Schibli*ac Abstract: The concept of targeted radionuclide therapy (TRT) is the accurate and efficient delivery of radiation to disseminated cancer lesions while minimizing damage to healthy tissue and organs. Critical aspects for success- ful development of novel radiopharmaceuticals for TRT are: i) the identification and characterization of suitable targets expressed on cancer cells; ii) the selection of chemical or biological molecules which exhibit high affin- ity and selectivity for the cancer cell-associated target; iii) the selection of a radionuclide with decay properties that suit the properties of the targeting molecule and the clinical purpose. The Center for Radiopharmaceutical Sciences (CRS) at the Paul Scherrer Institute in Switzerland is privileged to be situated close to unique infrastruc- ture for radionuclide production (high energy accelerators and a neutron source) and access to C/B-type labora- tories including preclinical, nuclear imaging equipment and Swissmedic-certified laboratories for the preparation of drug samples for human use. These favorable circumstances allow production of non-standard radionuclides, exploring their biochemical and pharmacological features and effects for tumor therapy and diagnosis, while investigating and characterizing new targeting structures and optimizing these aspects for translational research on radiopharmaceuticals. In close collaboration with various clinical partners in Switzerland, the most promising candidates are translated to clinics for ‘first-in-human’ studies. -
NIH Public Access Author Manuscript Nanomedicine
NIH Public Access Author Manuscript Nanomedicine. Author manuscript; available in PMC 2016 January 01. NIH-PA Author ManuscriptPublished NIH-PA Author Manuscript in final edited NIH-PA Author Manuscript form as: Nanomedicine. 2015 January ; 11(1): 31–38. doi:10.1016/j.nano.2014.07.004. Polysilsesquioxane Nanoparticles for Triggered Release of Cisplatin and Effective Cancer Chemoradiotherapy Joseph Della Rocca, Ph.D.a, Michael E. Werner, Ph.D.b, Stephanie A. Kramer, B.S.a, Rachel C. Huxford-Phillips, B.S.a, Rohit Sukumar, B.S.b, Natalie D. Cummings, B.A.b, Juan L. Vivero-Escoto, Ph.D.a, Andrew Z. Wang, M.D.b,c,*, and Wenbin Lin, Ph.D.a,c,d,* aDepartment of Chemistry, University of North Carolina, Chapel Hill, NC 27599 bLaboratory of Nano- and Translational Medicine, Department of Radiation Oncology, CB 7512 University of North Carolina School of Medicine, Chapel Hill, NC 27599, USA cLineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC 27599, USA dDepartment of Chemistry, University of Chicago, 929 East 56th St, Chicago, IL 60637, USA Abstract Chemoradiotherapy is a well-established treatment paradigm in oncology. There has been strong interest in identifying strategies to further improve its therapeutic index. An innovative strategy is to utilize nanoparticle (NP)chemotherapeutics in chemoradiation. Since the most commonly utilized chemotherapeutic with radiotherapy is cisplatin, the development of a NP cisplatin for chemoradiotherapy has the highest potential impact on this treatment. Here, we report the development of a NP comprised of polysilsesquioxane (PSQ) polymer crosslinked by a cisplatin prodrug (Cisplatin-PSQ) and its utilization in chemoradiotherapy using non-small cell lung cancer as a disease model. -
Thames Valley Chemotherapy Regimens Sarcoma
Thames Valley Thames Valley Chemotherapy Regimens Sarcoma Chemotherapy Regimens– Sarcoma 1 of 98 Thames Valley Notes from the editor All chemotherapy regimens, and associated guidelines eg antiemetics and dose bands are available on the Network website www.tvscn.nhs.uk/networks/cancer-topics/chemotherapy/ Any correspondence about the regimens should be addressed to: Sally Coutts, Cancer Pharmacist, Thames Valley email: [email protected] Acknowledgements These regimens have been compiled by the Network Pharmacy Group in collaboration with key contribution from Prof Bass Hassan, Medical Oncologist, OUH Dr Sally Trent, Clinical Oncologist, OUH Dr James Gildersleve, Clinical Oncologist, RBFT Dr Sarah Pratap, Medical Oncologist, OUH Dr Shaun Wilson, TYA - Paediatric Oncologist, OUH Catherine Chaytor, Cancer Pharmacist, OUH Varsha Ormerod, Cancer Pharmacist, OUH Kristen Moorhouse, Cancer Pharmacist, OUH © Thames Valley Cancer Network. All rights reserved. Not to be reproduced in whole or in part without the permission of the copyright owner. Chemotherapy Regimens– Sarcoma 2 of 98 Thames Valley Thames Valley Chemotherapy Regimens Sarcoma Network Chemotherapy Regimens used in the management of Sarcoma Date published: January 2019 Date of review: June 2022 Chemotherapy Regimens Name of regimen Indication Page List of amendments to this version 5 Imatinib GIST 6 Sunitinib GIST 9 Regorafenib GIST 11 Paclitaxel weekly (Taxol) Angiosarcoma 13 AC Osteosarcoma 15 Cisplatin Imatinib – if local Trust funding agreed Chordoma 18 Doxorubicin Sarcoma 21 -
Surgical Oncology 3 PGY3
Stanford University General Surgery Residency Program Surgical Oncology 3 / Endocrine Surgery Rotation Goals and Objectives Rotation Director: Dana Lin, MD Description The Surgical Oncology 3 / Endocrine Surgery rotation offers an intensive experience in the surgical care of patients with endocrine diseases as well as breast cancer and melanoma. Goals The goal of the Surgical Oncology 3 / Endocrine Surgery rotation is to: Gain the knowledge and experience in the evaluation and management of patients with endocrine diseases, breast cancer, and melanoma. The primary goals for the R-3 resident: Develop knowledge and experience in the evaluation and management of patients with endocrine diseases, breast cancer, and melanoma. Acquire and refine procedural and operative skills required in the care of these patients. Direct the post-operative / in-patient care of the patients on the service. Objectives The Surgical Oncology 3/ Endocrine Surgery R-3 rotation has the following objectives: The resident has primary responsibility for the management of all patients admitted to or evaluated by the team in conjunction with the attending surgeon. The R-3 gains knowledge of surgical care through discussion with and teaching from the attending physicians in the inpatient and outpatient setting, attendance at the multidisciplinary endocrine tumor board conference, as well as independent reading. The resident gains operative skills through pre-operative reading and preparation and by direct intra-operative teaching and guidance from the faculty. Residents can expect frequent teaching from members of the team, both at the bedside and during formal and informal sessions. Feedback and teaching is individualized to the needs of the residents.