Evaluation of quality control and initial imaging properties of labeled [68Ga]GaPSMA-11 by elution of Monrol [68Ge]/[68Ga] generator

Abstract

Background: The [68Ga]Cl3 precursor is not commercially available as a raw material or as a [68Ga]-labeled radiopharmaceutical. [68Ge]/[68Ga] generators are household type generators used to obtain [68Ga] radionuclide. In this study, the product quality control parameters of [68Ga]GaPSMA-11 radiotracer labeled with [68Ga]Cl3 obtained from a GMP certified [68Ge]/[68Ga] generator manufactured by “Eczacıbaşı Monrol Nuclear Products Co.” (Turkey) were investigated. We evaluated and reported the quality control data and the first clinical patient studies with this radiotracer. Biodistribution of [68Ga]-radiotracer by PET-CT was evaluated retrospectively. Twenty one patients with prostate cancer who agreed to participate in the study were included and underwent [68Ga]GaPSMA-11 injection and PET-CT imaging. Results: The initial elution yield of the generator was determinde as 75% with reproducible stability. The amount of [68Ga] in the eluate by the HCl elution fraction was found to be appropriate. Of the 21 patients referred to our department, 10 patients were included in the study for staging and 11 patients for evaluation of response to treatment. The [68Ga]GaPSMA-11 uptake was observed in primary tumor and metastasis foci in 11 patients with metastatic prostate cancer. Heterogeneous [68Ga]GaPSMA-11 uptake was observed in prostate cancer and metastasis areas. Conclusion: [68Ga]GaPSMA-11 radiopharmaceutical was synthesized from a new generator with good quality and satisfying PET-CT images were obtained.