Aspects of the problem of clinical trials of modern targeted radiopharmaceuticals

Abstract

According to the results of our study, the authors point of view on the problem of testing of radiopharmaceutical medicaments, is reflected, taking into account the active modern development of nuclear medicine. In the context, the issues of the structure characters of targeted radiopharmaceutical medicaments (RPM) are considered from their development to the organization of clinical trials in Russia and abroad. The characters of the fact that targeted ligands delivering active diagnostic and therapeutic isotopes to tumor cells do not have a biological effect by themselves, and the main active pharmaceutical ingredient, radionuclide, is used in the range of radiation doses allowed for diagnosis and therapy. In this context, the absence of the necessity for the first phase of clinical trials and simplification of the design of the second and the third phases is justified for diagnostic RPM. Approaches to clinical research of therapeutic RPMs are considered separately, taking into account the known pre-clinical and clinical results of their effectiveness and radiation safety. By way of a clinical case, scintigrams of researches of the effectiveness of imaging tumors and metastases are presented using various diagnostic RFLP by SPECT-CT and PET-CT methods, at which point we pay attention to the characters of carrying out clinical trials in cancer medicine of RPM with high-energy and the most promising -radionuclides.