Long-term performance evaluation of a novel 3.26 GBq 68Ge/68Ga generator

Abstract Background 68 Ga is a key radionuclide in PET due to its favorable decay properties, generator availability, and growing preclinical and clinical use of 68 Ga-labeled radiopharmaceuticals. The performance of the 68 Ge/ 68 Ga generator is critical for efficient 68 Ga utilization. Here, a novel modified TiO 2 -based 68 Ge/ 68 Ga generator ( 68 Ge activity: 3.26 GBq) was evaluated for long-term performance, including 68 Ga elution yield, 68 Ge breakthrough, and metal impurities (Ti, Fe and Zn), and was verified in radiolabeling applications. Results Over a two-year period, this generator maintained an average 68 Ga elution yield of 79.8 ± 3.2% ( n = 209, range: 70.8%–87.1%), an average 68 Ge breakthrough as low as 0.00003% ( n = 149, range: 0.0000035%–0.00031%), and Ti, Fe, and Zn concentrations well below the limit of 10 µg/GBq. The generator demonstrated compatibility with various precursors such as DOTA-TATE, Pentixafor and FAP-2286. Conclusion The enhancement of the 68 Ge(IV) loading capacity in the 68 Ge/ 68 Ga generator, along with improved 68 Ga elution efficiency, facilitates the rapid and efficient production of 68 Ga. This advancement contributes to the promotion and widespread adoption of 68 Ga-based radiopharmaceuticals and benefits more patients. Graphical abstract