ArticleAnnals of nuclear medicine2026
Phase I/IIa clinical trial of
Article in Annals of nuclear medicine, 2026. 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
objectiveThis Phase I/IIa study evaluated the safety, pharmacokinetics, internal radiation dosimetry, and image quality of cyclotron-produced ⁶⁸Ga-PSMA-11 synthesized using an automated module in a Japanese population.
methodsIn this single-center trial, nine Japanese men (3 healthy volunteers, 6 prostate cancer patients) received a single intravenous injection of ⁶⁸Ga-PSMA-11 (4.0 MBq/kg). Safety, pharmacokinetics (blood/urine), and internal radiation dosimetry (serial PET/CT) were assessed. Diagnostic performance was evaluated by lesion detection rates and image quality by quantitative metrics, including noise-equivalent count (NEC), to optimize the protocol.
resultsNo adverse events were observed. The automated synthesis process consistently yielded high-quality ⁶⁸Ga-PSMA-11, with a decay-corrected radiochemical yield of 2841 ± 584 MBq and a radiochemical purity > 99%. The kidneys received the highest absorbed dose, with an effective dose comparable to that reported in published data. The agent demonstrated rapid clearance, primarily via renal excretion (58.99% ± 11.34% in 6 h), with a biological half-life of approximately 3.8 h in whole blood. All histopathology-confirmed primary lesions were detected. Quantitative analysis indicated that high image quality was maintained even with substantially reduced acquisition times.
conclusionsCyclotron-produced ⁶⁸Ga-PSMA-11 is safe and exhibits favorable pharmacokinetics and dosimetry in a Japanese population. This exploratory Phase I/IIa trial suggests that the production method appears feasible.
trial registrationjRCT2022230014.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.