A comparison of routine 68GaGa-PSMA-11 preparation using Locametz and Illuccix kits

Approval of Locametz and Illuccix kits for the manufacture of [68Ga]Ga-PSMA-11 (gallium Ga68 gozetotide), a PET imaging agent for prostate cancer, as well as the corresponding therapeutic ([177Lu]Lu-PSMA-617 Pluvicto), has led to a rapid increase in demand for [68Ga]Ga-PSMA-11 PET imaging. Radiopharmaceutical manufacturers, using 68Ge/68Ga generators, may decide to adopt Locametz and/or Illuccix kits, which requires a comparison to select the most suitable kit for day-to-day use. The objective of this article is to compare both kits and provide guidance for selecting one for routine use, as well as evaluate labeling consistency of both kits during routine production. Additionally, we report our experience during 1.5 years of daily [68Ga]Ga-PSMA-11 production at our facility using both kits.BACKGROUNDApproval of Locametz and Illuccix kits for the manufacture of [68Ga]Ga-PSMA-11 (gallium Ga68 gozetotide), a PET imaging agent for prostate cancer, as well as the corresponding therapeutic ([177Lu]Lu-PSMA-617 Pluvicto), has led to a rapid increase in demand for [68Ga]Ga-PSMA-11 PET imaging. Radiopharmaceutical manufacturers, using 68Ge/68Ga generators, may decide to adopt Locametz and/or Illuccix kits, which requires a comparison to select the most suitable kit for day-to-day use. The objective of this article is to compare both kits and provide guidance for selecting one for routine use, as well as evaluate labeling consistency of both kits during routine production. Additionally, we report our experience during 1.5 years of daily [68Ga]Ga-PSMA-11 production at our facility using both kits.Locametz (n = 181) and Illuccix (n = 256) kits were prepared using non-silicone coated and silicone-coated needles with 68Ga activities ranging from 0.53 to 3.16 GBq, with a failure rate of 1 in 128 runs for both kits. With Locametz, a 3.7 GBq generator and 10-min incubation at room temperature gave doses that passed quality control (QC) testing. Use of non-silicone coated needles in the process led to solution discoloration, and QC failure. Additionally, lack of vial inversion led to inconsistent labeling, which improved with subsequent vial agitation. For Illuccix, addition of the acetate buffer to the precursor vial prior to adding the [68Ga]GaCl3 simplifies the workflow. The maximum tolerated activity was 1.85 GBq. Lack of vial inversion led to failures, which were rectified by agitating the vial to properly incorporate the acetate solution with the generator eluate.RESUL