Estimation on clinical justification for the establishment of copper-64 radioisotope production and copper-64 radiopharmaceuticals application

Abstract

Establishing the production of radiopharmaceuticals and introducing new radiopharmaceuticals into healthcare practice in a developing country is challenging, primarily from an economic point of view. A feasibility study provides an objective assessment that takes into account not only the economic aspect but also the clinical impact and development of research potential. The first phase of the feasibility study for the establishment of copper-64 radioisotope production is a preliminary analysis, which aims to assess whether the introduction of 64Cu-radiopharmaceuticals into clinical use is possible and justified. The preliminary analysis includes a review of statistical data on malignant diseases on a national level based on reference databases, international and domestic, and a review of data on the clinical application of 64Cu-radiopharmaceuticals based on a reference database for clinical trials. As to the cancer statistics review, for a more objective insight into assessing the justification for introducing new radiopharmaceuticals into clinical use, data on malignancies in North Macedonia were compared with data related to the world, southern Europe and the European Union. The comparison focused on data relating to lung, cervical, and brain neoplasms as cancers examined in clinical trials involving [64Cu][Cu(ATSM)] radiopharmaceutical, one of the most widely explored 64Cu-radiopharmaceuticals. As can be seen from the comparison, cervical cancer has a lower incidence and mortality in Macedonia than in the world but a higher incidence and mortality compared to southern Europe and the countries of the European Union. Lung and brain cancers have a higher incidence and mortality in Macedonia than in all other compared regions. The results of the cancer statistic review indicate that it is rational to adopt strategies which can contribute to better management of malignant diseases in Macedonia. One of those potential strategies could be introducing new radiopharmaceuticals in nuclear medicine practice. As for solid malignant tumors, the detection of tumor hypoxia is of particular importance to optimize the treatment strategy and improve the overall prognosis. Positron emission tomography with hypoxia-avid radiopharmaceutical is a noninvasive method for measuring hypoxia, highly sensitive and directly quantitative. Considering the results of the preliminary analysis, it is reasonable to proceed to the next stages of the feasibility study for the establishment of the production of 64Cu radioisotope and the implementation of 64Cu-radiopharmaceuticals in clinical practice in Macedonia. Radiopharmaceuticals based on copper-64 radioisotope are promising due to the unique properties of this radionuclide that are complementary for diagnostic and/or therapeutic purposes.