DEVELOPMENT OF THE DESIGN OF THE PRECLINICAL TRIALS OF RADIOPHARMACEUTICALS FOR THE RADIONUCLIDE DIOAGNOSTICS AND THERAPY BASED ON THE AMBA PEPTIDE

Abstract

The use of the bombesin analogues labeled with 68Ga and 177Lu for the radionuclide diagnostics and therapy of the prostate cancer, respectively, is one of the novel and promising approaches of the nuclear medicine. These radiopharmaceuticals are currently on the stage of preclinical and clinical trials in the foreign countries; in the Russian Federation, a preclinical trial is being developed.
 The aim of the current study was to develop the design of the preclinical study for the radiopharmaceuticals based on AMBA for the assessment of their biodistribution.
 The study was based on the meta-analysis of the available publications in peer-reviewed journals. The analysis was performed using the full-text archive of biomedical and life sciences journals PubMed Central for the following keywords: radionuclide therapy, nuclear medicine, AMBA, 68Ga и 177Lu. The study included the comparative analysis of the animal and patient samples, methods of data collection and results of the accumulation of radiopharmaceuticals in nodules and radiosensitive organs and tissues.
 The results of the study allowed proposing the minimal requirements for the animal samples (at least 30 animals for each radiopharmaceutical), data collection (direct radiometry and PET) and time points (not less than 5 measurements in 120-240 minutes for the radiopharmaceuticals labeled with 68Ga and 5 measurements in 336 hours for the radiopharmaceuticals labeled with 177Lu) for the assessment of the biodistribution of the radiopharmaceuticals.