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JOINT RESEARCH CENTRE - Work Programme 2013
Action n° 51502 - AIT - Alpha-Immunotherapy
Institute for Transuranium Elements (Karlsruhe/Ispra)
Thematic Area:
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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:
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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:
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Objective 1:
Development of methods for the production of radionuclides and radionuclide
generators for clinical application
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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]
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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]
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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
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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]
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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]
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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
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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
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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
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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
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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