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

Abstract

Background

⁶⁸Ga is a key radionuclide in PET due to its favorable decay properties, generator availability, and growing preclinical and clinical use of ⁶⁸Ga-labeled radiopharmaceuticals. The performance of the ⁶⁸Ge/⁶⁸Ga generator is critical for efficient ⁶⁸Ga utilization. Here, a novel modified TiO₂-based ⁶⁸Ge/⁶⁸Ga generator (⁶⁸Ge activity: 3.26 GBq) was evaluated for long-term performance, including ⁶⁸Ga elution yield, ⁶⁸Ge 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 ⁶⁸Ga elution yield of 79.8 ± 3.2% (n = 209, range: 70.8%–87.1%), an average ⁶⁸Ge 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 ⁶⁸Ge(IV) loading capacity in the ⁶⁸Ge/⁶⁸Ga generator, along with improved ⁶⁸Ga elution efficiency, facilitates the rapid and efficient production of ⁶⁸Ga. This advancement contributes to the promotion and widespread adoption of ⁶⁸Ga-based radiopharmaceuticals and benefits more patients.

Graphical abstract