EUROPEAN PROJECTS

Clust-ER Health partner of the European PROJECT SECURE on radionuclides for therapeutic use

Another important step in the path of Clust-ER Health which, in addition to being among the partners of BIOMatDB+, will take part in SECURE, a 3-year European project on the theme of radionuclides for medical use.

A participation that represents, first of all, a success story for the history and activity of the Clust-ER. The registration of the Emilia-Romagna Region to the S3 partnership (with delegation to Clust-ER and ARTER for the activities) has in fact made it possible to lay the foundations for a collaboration that has led to the winning of a TAF (Technical Assistance Facility) project together with other partners, including Clusterul Regional Inovative de Imagistica Moleculara Si Structurala Nord-Est of Romania, the University of Lubijana and the current coordinator. It was precisely in this context, therefore, that the regional working table on radiopharmaceuticals was formed, which also involves the Romagnolo Institute for the Study of Tumors “Dino Amadori” – IRST IRCCS

Trace-MED – this is the name of the TAF project – aimed to create a framework at European level for the development of new radionuclides and their functionalization and was funded with a grant dedicated to the drafting of the business plan. A work that proved to be fundamental and functional to arrive, finally, at the presentation of a proposal for the HORIZON-EURATOM-2021 call, which also saw the involvement of ENEA, which materialized with a large consortium in the SECURE project.

Read also: TRACE-MED: SUPPORT PLAN FOR THE DEVELOPMENT OF RADIOPHARMACEUTICALS APPROVED

The objectives

The SECURE project, which will start in mid-2022, aims to make an important contribution to the sustainability of the production of medical isotopes and their safety of application in Europe, focusing on promising developments in the design of irradiation targets, production pathways for both existing and new isotopes in nuclear therapy and diagnostics. The critical isotopes useful for nuclear medicine will then be selected and the research activities useful to address some of the main challenges related to future availability will be identified, with the objectives of:

  • remove critical barriers along the production of selected alpha and beta emitter isotopes that limit sustainable production,
  • develop a framework of guidelines and recommendations to explore the full clinical potential of alpha and beta particle therapy and its safe application (including radiation protection considerations throughout the supply chain, as well as personalised planning and dosimetry aspects),
  • provide information to serve as a demonstration case to address problems related to the large-scale production of isotopes.

The goal of the SECURE consortium, made up of 17 partners and coordinated by the Narodowe Centrum Badan Jadrowych in Poland, is to identify and efficiently use current resources to produce new radionuclides, in particular for alpha emitters and related beta-emitting theranostic radionuclides, which would create new opportunities for society, healthcare and the economy. In particular, it will be crucial to fill the gap currently present in predicting an increased availability of Actinium-225 (225Ac, Ac-225), Lead-212 (Pb-212) and other related radionuclides. The development of alternative technologies for the production of such therapeutic radionuclides for the best treatment of patients requires multidisciplinary scientific and technological knowledge (physics, chemistry, materials science, processing of target materials, chemistry, biology and radiobiology, radiopharmacy and nuclear medicine), which is present within the large high-level and complementary partnership developed by the SECURE consortium.

Although the clinical applications of radionuclide therapy are gaining ground in recent years, their use still remains marginal compared to other therapeutic regimens, such as external beam radiotherapy and chemotherapy. This multidisciplinary project, which includes expertise in terms of production and provision of radioisotopes for therapeutic applications up to practical issues such as radiation protection throughout the supply chain (production, distribution, production and administration of tracers) and in clinical protocols (administration, personalized planning, dosimetry, clinical applications) will allow to address the efficiency and safety aspects of such radionuclides across the EU, including recommendations for further potential clinical applications, personalised treatment protocols and dosimetric calculations.

The role of the Clust-ER and the members involved in the project

Clust-ER Health, together with ENEN and IMAGO-MOL, will be among the main contributors to the dissemination, communication and exploitation of the project results. In particular, it will support communication activities through the publication of news and results on its website, social media and newsletter and will act, in Europe, as an ambassador of the project within the S3P4PM Partnership – European Personalized Medicine S3 together with IMAGO-MOL and in the S3 Medical Technologies Partnership.

ENEA, leader of WP2, is responsible for studying and testing the physical and radiochemical processes for the production of short-term radionuclides used in diagnosis and therapy such as Tc-99m, Cu-64, Lu-177, Tb-161 using nuclear fission reactors (TRIGA and TAPIRO), 14 MeV fusion sources (FNG and Sorgentina-RF). It will also provide Standard Am-Be neutron sources and a thermal neutron flux density standard with accurate characterization of the neutron spectrum and radioactivity standards (INMRI). ENEA will also perform simulation modelling of the target and dose rate and develop an approach to nuclear safety and physical protection of the entire supply chain. All WP2 partners will therefore benefit from the neutron standards and activities developed and maintained at ENEA-INMRI.

IRST, which has extensive experience in clinical dosimetry of patients and in developing recommendations to ensure the safety of new treatment options using radionuclides for all involved, will play an important role in WP4 and in particular in the development of recommendations for clinical applications in rare cancers. In addition, the IRST will carry out a risk assessment and a radiological life cycle assessment (LCA) to describe various exposures using, where possible, the existing methodologies described in the EU Radiation Protection Guidelines. The IRST will also contribute to the modeling of dose distribution and optimization for the patient for treatment scenarios and will perform dose distribution measurement.

The Clust-ERs are financed by the European Funds of the Emilia-Romagna Region - ERDF ROP 2014-2020