Production of cyclotron-based Gallium-68 radioisotope and related radiopharmaceuticals

Theranostic radiopharmaceuticals have attracted enormous interest in the last decade and several radiopharmaceuticals have been developed based on related radionuclides (Lu-177, Y-90, Ga-68, Cu-61,64,67, ...). IAEA has already initiated/completed separate successful CRPs on Lu-177, Y-90, Cu-series, Sc-47 and Ga-68 (generator-based) covering all aspects of production, radiopharmaceutical development, quality control as well as preclinical studies. Among these, 68Ga-based radiopharmaceuticals have attracted increasing interest in recent years due to their expanding clinical applications and availability of generators well covered within a former CRP (F22050). This interest is fostered by the growing clinical use of theranostic applications in oncology where a diagnostic scan is performed with a gallium-based PET agent to select patients who will benefit from targeted therapies using agents containing therapeutic radionuclides such as 90Y or 177Lu. While currently 68Ga is mainly coming from 68Ge/68Ga generators, supply challenges for 68Ga remain. To this end, the IAEA has published the TECDOC-1863 ‘Gallium-68 Cyclotron Production’ in February 2019. Recent response to this TECDOC and inquiries demonstrate that due to the complex technology involved, Member States are looking for more guidance on how to implement alternative 68Ga production. The purpose of this Coordinated Research Project is provide assistance and sharing Member States experience on  cyclotron-produced 68Ga in the field of direct radionuclide production, radiopharmaceutical production, QC/QA and regulatory aspects for ultimate use in clinical applications. As the technology developed and shared will also be suitable for the production of several other radiometals.