Optimization of Automated Radiosynthesis of Gallium-68-Labeled PSMA11 with Two [68Ge]Ge/[68Ga]Ga Generators: Fractional Elution or Prepurification?

• Published in: Pharmaceuticals (Basel, Switzerland) Vol. 16; no. 11; p. 1544
• Main Authors: Durieux, Flore, Dekyndt, Bérengère, Legrand, Jean-François, Rogeau, Antoine, Malek, Emmanuel, Semah, Franck, Odou, Pascal
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 01.11.2023; MDPI
• Series: Pharmaceuticals
• Subjects: [68Ga]Ga-PSMA-11; Antigens; double elution; Hypotheses; Labeling; Life Sciences; Methods; Optimization; Prostate cancer; Quality control; radiopharmacy; Belgium; France; [68Ga]Ga-PSMA-11; double elution; radiopharmacy
• ISSN: 1424-8247; 1424-8247
• DOI: 10.3390/ph16111544

Prostate cancer is one of the most common forms of cancer in men. An imaging technique for its diagnosis is [68Ga]-prostate-specific membrane antigen ([68Ga]Ga-PSMA-11) positron emission tomography (PET). To address the increasing demand for [68Ga]-labeled peptides and reduce the cost of radiosynthesis, it is therefore necessary to optimize the elution process of [68Ge]Ge/[68Ga]Ga generators. This study aims to identify the most effective approach for optimizing radiosynthesis using double elution in parallel of two [68Ge]Ge/[68Ga]Ga generators. Two methods have been tested: one using prepurification, and the other using fractionated elution. Five synthesis sequences were conducted using each method. The mean labeling yields for double elution with prepurification were 45.8 ± 29.4 (mean ± standard deviation) and none met the required criteria. The mean labeling yields for the fractionated double elution were 97.5 ± 1.9 (mean ± standard deviation) meeting the criteria, significantly superior to the prepurification method (p = 0.012), and similar to those of simple elution. This study showed that fractionated double elution from [68Ge]Ge/[68Ga]Ga generators produced a significantly higher labeling yield than double elution with prepurification, resulting in a larger activity recovered via radiosynthesis, thereby allowing more diagnostic tests to be performed.