Speaker
Descrizione
Glioblastoma represents the most frequent malignant primary brain tumor, with a median overall survival of approximately 15 months and a 5-year survival rate close to 5%. In this setting, positron emission tomography (PET) using O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET) has demonstrated significant value for diagnosis, treatment planning, and therapy monitoring.
Despite the strong clinical evidence, the limited national availability of [18F]FET has historically restricted its widespread adoption in routine practice in Italy.
The PROFETI project was conceived to overcome this barrier by establishing a coordinated
network integrating research institutions, industrial partners, and local healthcare stakeholders. The initiative aimed to enable multi-site GMP production and create the conditions for sustainable distribution of the radiopharmaceutical.
Building on the technology transfer activities initiated in Pisa, PROFETI supported the
implementation of [18F]FET manufacturing capabilities in additional Italian sites, including Rome, Udine, and Milan, through a structured pathway based on:
• definition of functional and performance requirements;
• validation of analytical methods and comprehensive personnel training;
• process validation and harmonization across sites;
• preparation for regulatory submission to the Italian Medicines Agency (AIFA);
• development of a collaborative framework for continuous quality improvement and shared
problem solving.
The creation of an Italian network of GMP-authorized centers represents a major advancement in the national exploitation of public healthcare investments, ensuring broader and more equitable access to advanced molecular imaging.
This coordinated effort has the potential to significantly impact the management of more than 6,500 patients diagnosed with glioma every year in Italy, enabling standardized, high-quality diagnostic support and fostering future clinical and research applications.
