Commercial 68Ge/68Ga Generators: routine quality evaluation methods and their detailed comparison

Abstract: 68Ge/68Ga generator is more attractive one to prepare two most valuable 68Ga-PSMA (for prostate cancer) and 68Ga-DOTATATE (for neuroendocrine tumor) PET radiopharmaceutical. The performance of 68Ge/68Ga generators will affect the radiolabeling condition as well as radiopharmaceutical quality and per patient cost. This review study outlines the criteria’s and the routine evaluation procedures like elution profile and efficiency, eluent radio-nuclide, radiochemical and chemical purity, and time dependence performance (68Ge breakthrough) for the 68Ge/68Ga generators and compare commercial available SnO2- (Pars isotope, Iran), organic-matrix- (ITG GmbH Germany), nano CeO2-PAN composite- (BARC-india), TiO2- (Eikert & Zeigler, Germany), SnO2- (iThemba Labs, South Africa) and SiO2- (ITG, Germany) based generators according to published data. The elution yields from the CeO2-based and SiO2-based 68Ge/68Ga generators are almost consistent over-time; in contrast a sharp decrease observed in the elution yields from TiO2 and SnO2-based generators is observed. The level of 68Ge impurity in 68Ga eluates from the organic-matrix-, CeO2 and SiO2-based generators was always <0.001%, while this level increased to 0.01% for the TiO2 and SnO2-based generators. The 68Ga eluent from organic matrix based generator is almost free from metallic cation impurity. However, this impurity was <0.1 (for CeO2-PAN- and SiO2-based generator and was 1-20 ppm (for TiO2- and SnO2-based generator). The organic-matrix- based generator is the best one for preparing 68Ga PET radiopharmaceuticals like 68Ga-DOTATATE and 68Ga-PSMA. The nano CeO2-PAN composite- and SiO2- based have quite reliable quality but the SnO2- (from iThemba Labs and Pars Isotope) and TiO2- (from Eikert & Zeigler) based generator need more attention to monitor the 68Ga eluate quality and radiolabeling conditions (quantity of reactive material, pH and temperature). It is recommended that the Pars-isotope company investigates to upgrade the Iran made 68Ge/68Ga generator.

کلیدواژه ها:

PET radiopharmaceuticals ، 68Ge/68Ga generator ، quality ، 68Ge breakthrough ، 68Ga eluate