Annals of nuclear medicine · 2026
Phase I/IIa clinical trial of 68Ga-PSMA-11 synthesized by a newly developed automated module using cyclotron-generated 68Ga.
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Sugawara Shigeyasu, Okamoto Shozo, Kanno Noriko, Ukon Naoyuki, Joho Taiki, Takahashi Kazuhiro, Hoshi Seiji, Kojima Yoshiyuki, Hashimoto Yuko, Ito Yoichi M, Hanada Kazuhiko, Kobayakawa Masao, Oriuchi Noboru, Shiga Tohru
Аннотация
OBJECTIVE: This 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.
METHODS: In 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.
RESULTS: No 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.
CONCLUSIONS: Cyclotron-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 REGISTRATION: jRCT2022230014.
METHODS: In 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.
RESULTS: No 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.
CONCLUSIONS: Cyclotron-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 REGISTRATION: jRCT2022230014.