Safe use and reliable supply of medical radionuclides

Topic description

ExpectedOutcome:

Project results are expected to contribute to all of the following outcomes:

• Development of innovative routes of production of therapeutic and diagnostic radionuclides in EU, looking into reactor-based and alternative methods, including accelerator-based as well as separation / purification methods, also taking into account waste management options (EURAD), nuclear security and proliferation concerns.
• Development of optimised irradiation targets, that are interchangeable to allow use within the whole EU supply network, and prioritising production with raw and source materials which are available and sustainable for the EU.
• Development of recommendations for implementing clinical trials involving radiopharmaceuticals in the EU, including the development of individual/specific organ dosimetry for the therapeutic applications (in target and non-target tissues).
• Ensuring an adequate supply of radioisotopes for further research, clinical trials and clinical use with full implementation of radiation protection measures and with reduction of costs along the whole supply chain.

Therapeutic nuclear medicine is developing rapidly in oncology. Theranostics – the combination of diagnostics and therapy – is an emerging application of medical isotopes that exploits different properties of radioisotopes. Targeted radionuclide therapy, including alpha and beta therapy, is a promising approach for the treatment of cancer. Several alpha- and beta-emitting isotopes have demonstrated effectiveness in preclinical studies and clinical trials. Theranostic compounds are likely to make a difference to cancer patients in the near future not only through improvements in their quality of life but also in terms of survival rate. Appropriate availability of alpha- and beta-emitting radionuclides must be ensured to treat patients and enable investigation of feasibility of targeted radionuclide therapies.

The proposed research action should cover development of reactor-based and alternative, including accelerator-based, production of therapeutic and diagnostic radionuclides in order to address the lack of consistent supply, a major barrier for further research, clinical trials and clinical use. The action will cover development and optimisation of suitable targets for the different production modalities including target fabrication techniques for established and novel target nuclides (e.g. Ra-223, Lu-177, Ac-225, Re-188, Pb-212, At-211, etc. and related diagnostic radionuclides), possible raw and source materials and their availability, novel target solutions, radiochemistry for target dissolution, separation and quality assured purification of desired radionuclides.

Ensuring the safety of the new treatment options using radionuclides for all those involved (patients, medical staff, and public) is also a crucial area requiring further development. Research should cover activities such as: advanced means of generator-type delivery of the radionuclide and improvement of the application of Good Manufacturing Practices at the point of care, particularly if using “in-house labelling”; optimisation of treatment planning and individual/organ dosimetry; development of recommendations for clinical applications including sensitive groups (e.g. children) or rare diseases; review of ethical considerations; consultation of stakeholder groups.

Proposed actions should be complementary to the co-funded European Partnership for research in radiation protection under Topic HORIZON-EURATOM-2021-NRT-01-09 of this Work Programme, and with the other relevant programmes such as the Horizon Europe Health cluster, the SAMIRA action plan and the EU Beating Cancer Plan.

The Commission also invites consortia to propose innovative solutions and research approaches other than those listed above in order to deliver the expected outcomes.

An action could be carried out by a consortium of organisations such as research infrastructures, pharmaceutical industry, medical universities and hospitals.

Due to the scope of this topic, international cooperation is encouraged; however the action should be focused on developing radionuclide therapy capacities and resilience for Euratom Member States.

Where appropriate, the Commission recommends that consortia make use of the services of the JRC. The JRC may participate in the preparation and submission of the proposal. The JRC would bear the operational costs for its own staff and research infrastructure operational costs. The JRC facilities and expertise are listed in the General Annex H of this Work Programme.