Automated radiosynthesis of [⁶⁸ Ga]Ga-PSMA-11 and [¹⁷⁷ Lu]Lu-PSMA-617 on the iPHASE MultiSyn module for clinical applications.

ABSTRACT: Prostate-specific membrane antigen (PSMA)-targeted imaging and therapy of prostate cancer using theranostic pairs is rapidly changing clinical practice. To facilitate clinical trials, fully automated procedures for the radiosyntheses of [⁶⁸ Ga]Ga-PSMA-11 and [¹⁷⁷ Lu]Lu-PSMA-617 were developed from commercially available precursors using the cassette based iPHASE MultiSyn module. Formulated and sterile radiopharmaceuticals were obtained in 76 ± 3% (n = 20) and 91 ± 4% (n = 15) radiochemical yields after 17 and 20 min, respectively. Radiochemical purity was always >95% and molar activities exceeded 792 ± 100 and 88 ± 6 GBq/μmol, respectively. Quality control showed conformity with all relevant release criteria and radiopharmaceuticals were used in the clinic.

SUBMITTER: Wichmann CW 

PROVIDER: S-EPMC8048907 | biostudies-literature |

REPOSITORIES: biostudies-literature