Good Management Practices of Cyclotron Based Gallium-68 Radiopharmaceuticals

Theranostic radiopharmaceuticals deliver radioactive isotopes to targeted tissues, enabling accurate tumour imaging and effective cancer treatment. Interest in these pharmaceuticals has grown significantly over the past decade, with positron-emitting radionuclides such as Gallium-68 (68Ga) increasingly used for personalised diagnosis and therapy monitoring. To support international efforts in this field, the International Atomic Energy Agency (IAEA) launched the coordinated research project (CRP) Production of Cyclotron Based Gallium-68 Radioisotope and Related Radiopharmaceuticals (F22073), in 2020. The CRP facilitated the increased availability of high-quality 68Ga for radiolabelling by promoting the exchange of expertise on cyclotron-based production using the 68Zn(p,n)68Ga route. It also addressed radiopharmaceutical production, quality control, quality assurance, and regulatory considerations for clinical applications. This TECDOC presents contributions from experts and key outcomes of the CRP.