Good practices for 68Ga radiopharmaceutical production

Background The radiometal gallium-68 (Ga-68) is increasingly used in diagnostic positron emission tomography (PET), with Ga-68-labeled radiopharmaceuticals developed as potential higher-resolution imaging alternatives to traditional Tc-99m agents. In precision medicine, PET applications of Ga-68 are widespread, with Ga-68 radiolabeled to a variety of radiotracers that evaluate perfusion and organ function, and target specific biomarkers found on tumor lesions such as prostate-specific membrane antigen, somatostatin, fibroblast activation protein, bombesin, and melanocortin. Main body These Ga-68 radiopharmaceuticals include agents such as [Ga-68]Ga-macroaggregated albumin for myocardial perfusion evaluation, [Ga-68]Ga-PLED for assessing renal function, [Ga-68]Ga-t-butyl-HBED for assessing liver function, and [Ga-68]Ga-PSMA for tumor imaging. The short half-life, favourable nuclear decay properties, ease of radiolabeling, and convenient availability through germanium-68 (Ge-68) generators and cyclotron production routes strongly positions Ga-68 for continued growth in clinical deployment. This progress motivates the development of a set of common guidelines and standards for the Ga-68 radiopharmaceutical community, and recommendations for centers interested in establishing Ga-68 radiopharmaceutical production. Conclusion This review outlines important aspects of Ga-68 radiopharmacy, including Ga-68 production routes using a Ge-68/Ga-68 generator or medical cyclotron, standardized Ga-68 radiolabeling methods, quality control procedures for clinical Ga-68 radiopharmaceuticals, and suggested best practices for centers with established or upcoming Ga-68 radiopharmaceutical production. Finally, an outlook on Ga-68 radiopharmaceuticals is presented to highlight potential challenges and opportunities facing the community.

Automated summary

Ga-68 is increasingly used in PET for higher-resolution imaging and has widespread applications in precision medicine. Guidelines and standards for the Ga-68 radiopharmaceutical community and recommendations for centers interested in establishing Ga-68 radiopharmaceutical production are necessary for continued growth in clinical deployment.