ArticleEJNMMI radiopharmacy and chemistry2025
Assessment of quality control and effect of radiolysis on the in vivo biodistribution of [
Article in EJNMMI radiopharmacy and chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundOne of the challenges in optimizing PSMA-based therapies for the treatment of prostate cancer is the stability of the radiopharmaceutical, defined by the degradation of radiolabeled compounds due to exposure to ionizing radiation (radiolysis). Radiolysis of a radiopharmaceutical is difficult to measure and can influence the biodistrubion of radiopharmaceuticals in vivo, possibly leading to toxicity or suboptimal outcomes. Therefore, an inter-laboratory study was performed to confirm accurate detection of radiolysed [
resultsMultiple HPLC-methods were compared to evaluate the analysis of degraded radiopharmaceutical and an inter-laboratory comparison was conducted to evaluate the consistency of current analytical methods across various institutions and with current methods from literature. Additionally, for the biodistribution experiments, a radiolabeling of [
conclusionThe inter-laboratory study confirms that impurities caused by radiolysis can be measured accurately across different institutions, ensuring consistency and reliability in clinical diagnostics and therapy, contributing to improved patient safety. Phosphate buffered HPLC-methods showed no significant benefits in quality control. Increased impurities caused by radiolysis lead to lower tumor-to-kidney ratios, with a decrease in specific tumor binding.
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