Speaker
Descrizione
Within the Tuscany Health Ecosystem, Spoke 1 – WP8 is dedicated to the synthesis and production of tumor-targeted radionuclides, radiotracers and radiopharmaceuticals intended for clinical use.
The overarching objective is to ensure the availability of medicinal products authorized for
administration in humans, supporting diagnosis and follow-up of patients affected by glioma and other oncological and neurological diseases.
The work package focused on three major translational pathways: technology transfer and GMP authorization of Fluoroethyl-L-tyrosine, technology transfer of Fluorodopa, and process validation activities for FAPI-74.
For [18F]FET, the transfer technology transfer was successfully finalized in February and GMP
authorization was released from Agenzia Italiana del Farmaco (AIFA) in April 2024, enabling
routine clinical availability of the tracer in Italy.
Technology transfer for [18F]FDOPA was completed in September 2024, followed by national
regulatory authorization released in August 2025, further strengthening the infrastructure for
molecular imaging in neurology, particularly in parkinsonian syndromes.
In parallel, the WP achieved production of three consecutive validation batches of [18F]FAPI-74 under controlled conditions. This radiopharmaceutical will be manufactured under AIFA
authorization within prospective clinical investigations, including the DETECT Study, aimed at
evaluating [18F]FAPI PET in hepatocellular carcinoma, and the TARG Study, focused on targeting the tumor microenvironment in gliomas.
Overall, WP8 represents a concrete example of rapid translation from research to clinical
application, reinforcing regional and national capacity to deliver innovative, GMP-compliant
radiopharmaceuticals and to support multicenter clinical research.
