Studies of adequacy of radiolabeling of PSMA-1007 with fluorine-18 : validation of the analytical methodology and pre-clinical evaluation in the diagnosis of prostate cancer

• Grant number: 19/10110-4
• Support type: Scholarships in Brazil - Master
• Effective date (Start): June 01, 2019
• Effective date (End): May 31, 2021
• Field of knowledge: Engineering - Nuclear Engineering - Applications of Radioisotopes
• Principal researcher: Elaine Bortoleti de Araújo
• Grantee: Carolina Silva Ferreira dos Santos
• Home Institution: Instituto de Pesquisas Energéticas e Nucleares (IPEN). Secretaria de Desenvolvimento Econômico (São Paulo - Estado). São Paulo , SP, Brazil
• Associated research grant: 17/50332-0 - Scientific, technological and infrastructure qualification in radiopharmaceuticals, radiation and entrepreneurship for health purposes (PDIp), AP.PDIP

Abstract

In Brazil, prostate cancer (PC) is the second most common cancer among men, where the disease has treatments ranging from surgery to radiotherapy. Currently, several imaging exams such as positron emission tomography associated with computed tomography are used for the identification and evaluation of cancer. Today it has several specific radiotracers where prostate-specific membrane antigen (PSMA) radiolabeled have been presented so far as the most sensitive and specific for CP detection. The currently widely used PSMA-11-68Ga radioligand has high detection rates, while the newly developed PSMA-1007-18F has some advantages over Gallium-68, which includes its low emission of positron energy results in a high PET/CT image resolution. As the PSMA-1007-18F compound is unregistered, it requires the development of analytical methods that provide safety, quality and reproducibility in the results. Thus, the objective of this project will be to evaluate its synthesis, quality control and biodistribution through the investigation of the literature and laboratory tests to validate and document the procedures available for future registration and applications. The assays that will be carried out in this work includes evaluations of radiochemical purity, residual solvents, specific binding studies, internalization, in vitro and in vivo stability and biodistribution. PET images will be performed to assess their specificity and in vivo sensitivity. (AU)