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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>No adverse events were observed. The automated synthesis process consistently yielded high-quality \u2076\u2078Ga-PSMA-11, with a decay-corrected radiochemical yield of 2841\u2009\u00b1\u2009584 MBq and a radiochemical purity\u2009&gt;\u200999%. 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% \u00b1 11.34% in 6\u00a0h), with a biological half-life of approximately 3.8\u00a0h 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Cyclotron-produced \u2076\u2078Ga-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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>jRCT2022230014.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s12149-026-02262-5","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T08:31:24Z","timestamp":1784881884000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Phase I\/IIa clinical trial of 68Ga-PSMA-11 synthesized by a newly developed automated module using cyclotron-generated 68Ga"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8795-8099","authenticated-orcid":false,"given":"Shigeyasu","family":"Sugawara","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shozo","family":"Okamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Kanno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoyuki","family":"Ukon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taiki","family":"Joho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seiji","family":"Hoshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiyuki","family":"Kojima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Hashimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoichi M","family":"Ito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiko","family":"Hanada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masao","family":"Kobayakawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noboru","family":"Oriuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tohru","family":"Shiga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,24]]},"reference":[{"issue":"8","key":"2262_CR1","doi-asserted-by":"publisher","first-page":"1088","DOI":"10.1007\/s10147-024-02575-3","volume":"29","author":"T Sasaki","year":"2024","unstructured":"Sasaki T, Higashi T, Inoue T. 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