68Ga-labeled PSMA-11 (68Ga-isoPROtrace-11) Synthesized with Ready to Use Kit: Normal Biodistribution and Uptake Characteristics of Tumour Lesions

68Ga-PSMA-11, the radiotracer of choice for imaging of prostate cancer (PCa), may be produced with several radiolabeling techniques. Current study aimed to analyze various imaging parameters of the cold kit methodology produced 68Ga-PSMA-11 (68Ga-isoPROtrace-11) and to compare the results to available data in literature. Eighty 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) scans were evaluated. 68Ga-isoPROtrace-11 for all the studies was produced by the room temperature cold kit methodology using a lyophilized ready-to-use vial. Normal biodistribution of the tracer was recorded by measuring mean standardized uptake value (SUVmean) and compared to the available published data. Pathological tracer uptake was measured using SUVmax in prostate gland (48 patients), lymph nodes (22 patients), bones (20 patients) and soft tissues (6 patients). Average tumour-to-background and tumour-to-liver contrast ratios were calculated. The data of 80 68Ga-PSMA-11 PET/CT scans were analyzed. Radiochemical purity of the tracer was 91% or more. The highest normal tissue uptake value of 68Ga-isoPROtrace-11 was found in the kidneys (average SUVmean 41.7), followed by the parotid (average SUVmean 14.5) and submandibular glands (average SUVmean 13.02). Normal prostate tissue showed low tracer uptake (average SUVmean 2.4). The biodistribution of 68Ga-isoPROtrace-11 in normal tissues was found to be similar to other published results. Pathological uptake (average SUVmax ± standard deviation) in prostate gland was 11.3 ± 7.5, in lymph node metastases 14.6 ± 13.7, in bones 15.9 ± 15.9 and 24.2 ± 16.4 in soft tissues. Average tumour uptake of 68Ga-isoPROtrace-11 in prostate was 11.3, in lymph node metastases 14.6, in bone metastases 15.9 and in soft tissue metastases 24.2. Average tumour-to-liver and tumour-to-mediastinal blood pool ratios were 2.7 and 13.54 respectively. This study presents biodistribution data of 68Ga-isoPROtrace-11 in a large PCa patient subset, showing clinical applicability of the tracer. Using cold kit technology may enable a high quality and easy labeling process.