Optimized production and quality control of 68Ga-DOTATATE

Introduction: Optimized production and quality control of 68Ga-DOTATATE as an efficient and preferable PET radiotracer for somatostatin receptor imaging in neuroendocrine tumors is of great interest. In this study effort has been made to present a fast, efficient, cost-effective and facile protocol for 68Ga-DOTATATE productions for clinical trials. Methods: 68Ga-DOTATATEwas prepared using generator-based [68Ga]GaCl3 and DOTATATE at optimized conditions for time, temperature, ligand amount, gallium content and column cartridge purification followed by proper formulation. The biodistribution of the tracer in rats was studied using tissue counting and PET/CT imaging up to 120 min. Results: 68Ga-DOTATATE was prepared at optimized conditions in 7-10 min at 95C followed by SPE using C18 cartridge (radiochemical purity99±0.88% ITLC, >99% HPLC, specific activity: 1200-1850 MBq/nM). The biodistribution of the tracer demonstrated high kidney uptake of the tracer in 10-20 min consistent with reported somatostatin receptor mappings. Conclusion: The entire production and quality control of 68Ga-DOTATATE is presented including labeling, purification, HPLC analysis, sterilization and LAL test) took 18-20 min with significant specific activity for administration to limited number of patients in a PET center.