68Ga-PSMA-11: Optimized manual production and quality control for PET-CT imaging of prostate cancer

Background: 68Ga-PSMA-11, produced by an automatic radiolabeling module, is currently used for imaging of almost all prostate cancers. In this research, according to the chemical nature of the PSMA-11, a manual, optimized and safe production of this radiopharmaceutical has been investigated and a standard method has been presented to achieve a repeatable quality with the use of an Iran made 68Ge/68Ga generator.Methods: The effect of the PSMA-11 weight, temperature, pH, and radiolabeling time on the radiochemical purity (RCP) was evaluated. The effectiveness of the optimized condition on the quality of radiopharmaceutical was studied according to US Pharmacopeia guidelines. Also, by monitoring the absorption dose of the personnel, the safety of the manual production was checked.Results: Increasing the temperature from room temperature (RT) to 40◦C enhanced the RCP of 10μg of PSMA-11 to acceptable ranges above 90%. The higher weights (25 and 50 μg) had RCPs> 90% at RT. The appropriate pH range was determined to be 5-6. The 10 minutes reaction time yielded a repeatable RCP> 90% for the 10 μg PSMA-11. Body and hands dose rate was 15% and 2.4% of the recommended annual dose rate limit for body and hands, respectively.Conclusion: The results indicate the high quality of the Iran made 68Ge/68Ga generator. PET-CT centers can manually, safely and with repeatable quality produce 68Ga-PSMA-11 for prostate cancer imaging away from the challenge of transport problems. However, the accurate control of the radiolabeling conditions and the routine quality control of the product is necessary to be done by appropriately trained personnel.

کلیدواژه ها:

Prostate cancer ، PET-CT ، PSMA-11 ، Manual production