Background <p><sup>68</sup>Ga is a key radionuclide in PET due to its favorable decay properties, generator availability, and growing preclinical and clinical use of <sup>68</sup>Ga-labeled radiopharmaceuticals. The performance of the <sup>68</sup>Ge/<sup>68</sup>Ga generator is critical for efficient <sup>68</sup>Ga utilization. Here, a novel modified TiO<sub>2</sub>-based <sup>68</sup>Ge/<sup>68</sup>Ga generator (<sup>68</sup>Ge activity: 3.26 GBq) was evaluated for long-term performance, including <sup>68</sup>Ga elution yield, <sup>68</sup>Ge breakthrough, and metal impurities (Ti, Fe and Zn), and was verified in radiolabeling applications.</p> Results <p>Over a two-year period, this generator maintained an average <sup>68</sup>Ga elution yield of 79.8 ± 3.2% (<i>n</i> = 209, range: 70.8%–87.1%), an average <sup>68</sup>Ge breakthrough as low as 0.00003% (<i>n</i> = 149, range: 0.0000035%–0.00031%), and Ti, Fe, and Zn concentrations well below the limit of 10&#xa0;µg/GBq. The generator demonstrated compatibility with various precursors such as DOTA-TATE, Pentixafor and FAP-2286.</p> Conclusion <p>The enhancement of the <sup>68</sup>Ge(IV) loading capacity in the <sup>68</sup>Ge/<sup>68</sup>Ga generator, along with improved <sup>68</sup>Ga elution efficiency, facilitates the rapid and efficient production of <sup>68</sup>Ga. This advancement contributes to the promotion and widespread adoption of <sup>68</sup>Ga-based radiopharmaceuticals and benefits more patients.</p> Graphical abstract <p></p>

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

  • Xiaoyang Hu,
  • Renxin Hu,
  • Yao Yang,
  • Yuping Li,
  • Yan Zhao,
  • Ning Liu,
  • Qiang Ge,
  • Shuang Zhang,
  • Songdong Ding

摘要

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