Clinical trial of the radiopharmaceutical for diagnostic purposes “68Ga-FAPI-46” for PET use authorized
The Italian Medicines Agency (AIFA) has authorized the Nuclear Medicine of Santo Stefano di Pratoof the AUSL Toscana Centro della Toscana, at clinical trial of the radiopharmaceutical for diagnostic purposes “68Ga-FAPI-46” for PET use (nuclear medical imaging technique with positron emission tomography) in cancer patients.
The non-profit interventional study entitled “68Ga-FAPI-46 PET/CT for the molecular evaluation of fibroblast activation and risk in solid tumors” will be conducted in collaboration with IRCCS Romagnoli Institute for the study of tumors “Dino Amadori” of Emilia Romagna.
The study for Nuclear Medicine at the Prato hospital was largely financed with the contribution of the Sandro Pitigliani Foundation, which has been involved in the fight against tumors for years.
Dr. Stelvio Sestini, director of the facility, explains: “68Ga-FAPI-46 is a radiotracer inhibitor of the fibroblast activation protein (FAP) associated with cancer or, in simpler words, it is able to recognize and bind selectively to this glycoprotein which is present in large quantities on the membrane of these cells. This is very important – continues Sestini – because cancer-associated fibroblasts represent approximately 80% of the fibroblasts present in the tumor microenvironment and have a crucial role in the genesis of most solid tumors such as brain, breast, lung or of intestinal ones. It is therefore a bio-molecular imaging method capable of detecting the tumor selectively and very early.”
The technique for using 68Ga-FAPI-46 is very simple, i.e. it is based on the administration of the radiopharmaceutical intravenously and the subsequent acquisition (10 min) of images of the distribution of the radiopharmaceutical in the human body using the PET tomography. The presence of fibroblasts and therefore of the tumor is visualized in the bio-molecular images as an area of accumulation of the radiopharmaceutical 68Ga-FAPI-46.
“The radiopharmaceutical 68Ga-FAPI-46 – adds the technical health coordinator of medical radiology, Dr. Christian Mazzeo – is not available on the market but its synthesis will be carried out at the Radiopharmacy of Nuclear Medicine, present on Boxing Day, by highly qualified technical personnel. qualified. The success lies precisely in the recognition by AIFA of the ability of our team to correctly carry out all the synthesis and control phases of the radiopharmaceutical, something on which we have worked for at least 1 year together with our radiochemist Dr. Rino D’Agata and to Dr. Elisa Landi of the Corporate Clinical Trials Task Force of the Ethics and Care operational structure, without whose contribution we would not have been able to finalize this result”.
“Thanks are due – concludes Sestini – to the Corporate Management of the USL Toscana Centro and to the Sandro Pitigliani Foundation for the concrete support shown in the realization of the project, and to the team of IRCCS Romagnoli Institute for the study of tumors “Dino Amadori” of Emilia Romagna in particular in the figures of the radiochemists Dr. Stefano Boschi and Dr. Valentina Di Iorio”.
Dr. Maria Teresa Mechi, medical director of the facility, highlighted: “the possibility of carrying out research and clinical trials in the Prato hospital represents an important goal at the moment: only a few centers in Italy manage to obtain this authorization process as the required requirements at Aifa are very complex, from the organization of the structure to the necessary equipment up to the dedicated staff. It is therefore an excellent result for Nuclear Medicine and for our Healthcare Company.”
The Nuclear Medicine of Prato, which belongs to the Diagnostic Imaging Department, directed by Dr. Maurizio Bartolucci, is the only one of the USL TC Company and, recently, it was also certified as a structure, among the few in Italy, for the quality of management in particular of the primary processes of Radiopharmacy and bio-molecular diagnostics; it was then included by the pharmaceutical industry in the 10th position in the European ranking of the best Nuclear Medicines behind centers of proven fame such as Kings College Hospital in London or the Karolinska Universitetssjukhuset in Stockholm.
