Development of the design of the preclinical trials of radiopharmaceuticals for the radionuclide diagnostics and therapy based on the AMBA peptide
The present study is related to one of the promising areas of nuclear medicine: the use of peptides - bombesin analogues, labeled with 68Ga - for diagnosis and 177Lu - for therapy of prostate cancer. In the Russian Federation, preclinical trials of similar radiopharmaceutical drugs are in the study design stage. The aim of the current study was to develop the design of the preclinical study for the radiopharmaceutical drugs to assess the biodistribution of a peptide, an analogue of bombesin, intended for the diagnosis and treatment of prostate cancer. 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.