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Objective <p>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.</p> Methods <p>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.</p> Results <p>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 &gt; 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&#xa0;h), with a biological half-life of approximately 3.8&#xa0;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.</p> Conclusions <p>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.</p> Trial registration <p>jRCT2022230014.</p>

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Phase I/IIa clinical trial of 68Ga-PSMA-11 synthesized by a newly developed automated module using cyclotron-generated 68Ga

  • 期刊论文

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  • 发表日期：

    2026年7月24日

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  • Shigeyasu Sugawara,
  • Shozo Okamoto,
  • Noriko Kanno,
  • Naoyuki Ukon,
  • Taiki Joho,
  • Kazuhiro Takahashi,
  • Seiji Hoshi,
  • Yoshiyuki Kojima,
  • Yuko Hashimoto,
  • Yoichi M Ito,
  • Kazuhiko Hanada,
  • Masao Kobayakawa,
  • Noboru Oriuchi,
  • Tohru Shiga

摘要

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.