Expanding 68Ga radiolabeling capacity: off-label use of PSMA-11 single vial cold kits through aliquoting and dual generator utilization

BACKGROUND: summary of product characteristics (SmPC), as well as pharmaco-economic and dosimetric evaluations. RESULTS: kit without compromising RCP. Elutions with dual generators proved efficient when the overall HCl 0.1 M volume was < 2.4 mL, resulting in activities reaching approximately 1.7 GBq with RCP ≥ 98%. High acidity or uneven distribution of aliquots caused pH variations and decreased RCP, causing a restricted number of failures (7%). Radiochemical yields achieved approximately 89% in refined standard procedures. Automated eluate fractionation greatly decreased radiation exposure to hands in comparison to manual handling. Pharmaco-economic evaluation showed significant cost savings per patient, with routine daily capacity ranging from 8 to 16 patients per kit, depending on generator age. CONCLUSIONS: Ga cold-kit radiopharmaceuticals.