Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
JOINT RESEARCH CENTRE - Work Programme 2013 Action n° 51502 - AIT - Alpha-Immunotherapy Institute for Transuranium Elements (Karlsruhe/Ispra) Thematic Area: TA5 Nuclear Safety and Security Policy Theme: 5 - The EURATOM programme Agenda No & Title: 5.1 - Nuclear waste management and environmental impact Sub-agenda No & Title: 5.1.5 - Medical applications from nuclear research Type:: Action Action Leader: MORGENSTERN Alfred JRC.E.5 External Customer and Stakeholder: Albert Einstein College of Medicine ERASMUS MEDICAL CENTER ROTTERDAM Institut de recherches subatomiques INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE INSTITUTE OF NUCLEAR CHEMISTRY AND TECHNOLOGY JOHANNES GUTENBERG UNIVERSITAET MAINZ Medical University of Warsaw Radiochemistry Department (Delft University of Technology) ST GEORGE'S HOSPITAL MEDICAL SCHOOL Technische Universität München UNIVERSITA DEGLI STUDI DI ROMA LA SAPIENZA University Hospital Basel University of Gothenburg Johns Hopkins School of Medicine Oak Ridge National Laboratory Paul Scherrer Institute Rutgers University University Hospital Heidelberg Customer DGs (inside the European Commission): Keywords: Health, cancer, TAT, Targeted Alpha Therapy, therapy, infectious diseases, radionuclides, radionuclide generators, alpha emitters, production methods, chelate molecules, radiobiology, pre-clinical testing, clinical study, training, radiation protection Rationale: Radionuclides are used in medicine for the diagnosis and treatment of various diseases, including some of the most frequent ones, like cancers, cardiovascular and brain diseases. Over 10000 hospitals worldwide use radioisotopes for the in vivo diagnosis or treatment of about 35 million patients every year, of which 9 million in Europe. In its communication on medical applications of ionizing radiation and security of supply of radioisotopes for nuclear medicine to the European Parliament and the Council COM(2010)423, the European Commission has identified key challenges in the field of nuclear medicine, in particular securing supply of radioisotopes for nuclear medicine and improving radiation protection of patients and staff. Subsequently, in its conclusions "Towards the Secure Supply of Radioisotopes for Medical Use in the European Union" the Council of the European Union has stressed the need for continued efforts to actively investigate economically feasible alternatives to the current radioisotope production methods and the isotopes currently used. In this context, the Alpha-immunotherapy (AIT) action at JRC-ITU is developing methods for the production of established as well as alternative radionuclides, and is studying their application for the treatment of cancer and infectious diseases as well as providing training to hospital staff on safe handling of alpha emitting radionuclides in hospital settings. The action is particularly focusing on the investigation of radionuclides emitting alpha radiation, in an approach called Targeted Alpha Therapy - TAT. TAT is taking advantage of the unique physical properties of alpha radiation, in particular its high energy and short path length in human tissue, to selectively address and destroy diseased cells while sparing surrounding healthy tissue and minimizing toxic side effects. JRC-ITU is presently the only facility within the European Union capable of producing the alpha emitters Actinium-225 and Bismuth-213 in clinically relevant levels. Due to ITU's unique facilities, the development of methods for the production of clinical grade alpha emitters, the synthesis of radioconjugates and their radiobiological testing in vitro are core competences of the action. Pre-clinical in vivo studies and patient trials are conducted in collaboration with hospitals and cancer research centres in Europe, USA and Australia, focusing on the development of targeted alpha therapy for the treatment of a variety of cancers as well as infectious diseases, in particular HIV infections. Summary of the project: The action contributes to all stages of the development of targeted alpha therapy from bench to bedside to support its clinical implementation for the treatment of cancer and infectious diseases. Furthermore it provides training to hospital personnel to assure safe handling of alpha emitters in clinical settings and to improve radiation protection for health care workers and patients. The development of improved methods for production of radionuclides and radionuclide generators are a core activity of the action. Chelate molecules suitable for the stable binding of alpha emitters, e.g. uranium-230 to biomolecules will be synthesized and tested and protocols for the synthesis of radioconjugates will be developed. Novel radioconjugates will be tested in vitro and pre-clinical studies and clinical trials will be performed in collaboration with partner hospitals. Here a main focus will be on clinical trials of peptide receptor radiotherapy for the treatment of neuroendocrine and brain tumours Training courses on the safe handling, detection, quantification and shielding of alpha emitting radionuclides in clinical settings will be provided to hospital personnel to improve radiation protection. The development of automated systems for synthesis and handling of radiopharmaceuticals is focussing on the reduction of radiation exposure to medical staff. Specific Objectives for 2013: Objective 1: Development of methods for the production of radionuclides and radionuclide generators for clinical application o SubObjective 1.1 : Clinical testing of high activity (> 50 mCi) Ac-225/Bi213 radionuclide generators Deliverable 1.1.1: 2013-07-31 00:00:00.0. Accrual of data on clinical performance of newly developed high-activity Ac225/Bi-213 radionuclide generators for preparation of radiopharmaceuticals for cancer treatment [JRC Scientific Support - Technical systems] Deliverable 1.1.2: 2013-12-31 00:00:00.0. Scientific publication on development and clinical testing of highactivity Ac-225/Bi-213 radionuclide generator [Scientific Publications] o SubObjective 1.2 : Development of a novel method for production of U230/Th-226 for application in cancer therapy Deliverable 1.2.1: 2013-07-31 00:00:00.0. Measurement of the excitation function of He-3 induced reactions on Th-230 [JRC Scientific Support - Technical systems] Deliverable 1.2.2: 2013-12-31 00:00:00.0. Scientific publication on measurement of excitation function for the reaction Th-230(He-3,3n)U-230 [Scientific Publications] o SubObjective 1.3 : Development of an U-230/Th-226 radionuclide generator for synthesis of Th-226 labelled radiopharmaceuticals Deliverable 1.3.1: 2013-07-31 00:00:00.0. Characterisation and testing of an U-230/Th-226 radionuclide generator based on extraction chromatography [JRC Scientific Support - Technical systems] Deliverable 1.3.2: 2013-12-31 00:00:00.0. Scientific publication on U-230/Th-226 radionuclide generator [Scientific Publications] Objective 2: Development of chelate molecules and labelling protocols for the synthesis of radioconjugates for clinical application o SubObjective 2.1 : Investigation of chelates for binding of U-230 to biological carrier molecules (phenanthroline and terpyridine derivatives) Deliverable 2.1.1: 2013-12-31 00:00:00.0. Scientific publication(s) on use of phenanthroline derivatives as chelates for U-230 [Scientific Publications] o SubObjective 2.2 : Development of a novel and optimized protocol for synthesis of Ac-225 labelled biomolecules Deliverable 2.2.1: 2013-12-31 00:00:00.0. Validated protocol for synthesis of Ac-225 labelled biomolecules [JRC Scientific Support - Validated methods, Reference methods and measurements] o SubObjective 2.3 : Development of an automated system for synthesis of Bi-213 labelled biomolecules for clinical application in collaboration with pharmaceutical industry Deliverable 2.3.1: 2013-12-31 00:00:00.0. Development and testing of a synthesis module for fully automated synthesis of Bi-213 labelled peptides [JRC Scientific Support - Technical systems] Objective 3: In vitro and in vivo testing of radioconjugates labelled with alpha emitting radionuclides to assess their potential for therapy of cancer and infectious diseases, including HIV infections Deliverable 3.1: 2013-12-31 00:00:00.0. Publications on the characterisation and testing of the therapeutic efficacy and toxicity of alpha emitter labelled biomolecules [Scientific Publications] Objective 4: Clinical testing of biomolecules labelled with alpha emitters for treatment of brain and neuroendocrine tumours Deliverable 4.1: 2013-12-31 00:00:00.0. Accrual of clinical data on therapeutic efficacy and toxicity of alpha emitter labelled biomolecules for treatment of neuroendocrine and brain tumours and publication(s) of clinical experience [Scientific Publications] Objective 5: Training of medical staff on safe handling of alpha emitting radionuclides in clinical settings to improve radiation protection for patients and healthcare workers Deliverable 5.1: 2013-12-31 00:00:00.0. Provision of training to hospital personnel on safe handling, detection, quantification and shielding of alpha emitting radionuclides [JRC Scientific Support - Training] Objective 6: 8th international symposium on targeted alpha therapy Deliverable 6.1: 2013-06-06 00:00:00.0. Co-organisation of the 8th international symposium on targeted alpha therapy [JRC Scientific Support - Scientific and policy reports] Last Updated 10/09/2012 13:30:48