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Multi-bed SPECT\/CT was conducted 3-, 24-, 48-, and 168-hours post-administration to calculate tumour and organ absorbed doses. Two methods (activity- and anatomy-based) were used for selecting and delineating tumours for dosimetry. Venous blood was collected for radioactivity measurement 30\u00a0min before <jats:sup>177<\/jats:sup>Lu-rhPSMA-10.1 administration, and 0.5-, 1.5-, 4-, 24-, and 48-hours post-administration.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Thirteen patients were enrolled; three received 5.55 GBq\/cycle and 10 received 7.40 GBq\/cycle. Mean absorbed doses were 0.266, 0.130 and 8.87\u00a0Gy\/GBq in kidneys, salivary glands, and tumours (activity-method), respectively, giving mean tumour-to-kidney and tumour-to-salivary ratios of 32.1 and 73.2, respectively. Tumour dose estimates were consistently higher with the activity-method vs. anatomy-method. Tumour absorbed doses decreased each cycle; Cycle 2 and 3 doses were ~\u200937% and ~\u200956% lower than Cycle 1 estimates, respectively. <jats:sup>177<\/jats:sup>Lu-rhPSMA-10.1 was rapidly cleared from the blood (effective half-life, 2.2\u00a0h). Imaging data showed mean effective half-lives to be 91.4, 33.7 and 45.4\u00a0h in tumours, kidneys, and salivary glands, respectively.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>\n              <jats:sup>177<\/jats:sup>Lu-rhPSMA-10.1 delivers high radiation doses to tumours vs. normal organs, facilitated by its favourable pharmacokinetics. Cumulative doses to normal organs were well within established tolerable limits, suggesting higher cumulative radioactivity could be administered in clinical trials. The observation of decreasing tumour absorbed dose with subsequent cycles also supports the exploration of front-loading radioactivity in Phase II.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00259-025-07313-z","type":"journal-article","created":{"date-parts":[[2025,5,5]],"date-time":"2025-05-05T20:01:25Z","timestamp":1746475285000},"page":"4414-4424","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Organ and tumour dosimetry of 177Lu-rhPSMA-10.1, a novel PSMA-targeted therapy: results from a Phase I trial"],"prefix":"10.1007","volume":"52","author":[{"given":"James","family":"Nagarajah","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyun","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luke","family":"Nordquist","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vikas","family":"Prasad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathaniel","family":"Scott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Stevens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Fongenie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Osborne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,5,6]]},"reference":[{"key":"7313_CR1","doi-asserted-by":"publisher","first-page":"34930","DOI":"10.18632\/oncotarget.9004","volume":"7","author":"TM Gorges","year":"2016","unstructured":"Gorges TM, Riethdorf S, von Ahsen O, Nasta\u0142 YP, R\u00f6ck K, Boede M, et al. 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The protocol was approved by each investigating site\u2019s Independent Ethics Committee prior to initiation.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"James Nagarajah reports research grants from Novartis and ABX. He has provided consulting\/teaching services for Novartis, ITM, and Bayer. Hyun Kim provides consulting services for Novartis. Luke Nordquist has no relevant financial or non-financial interests to disclose. Vikas Prasad reports personal fees, reimbursement of travel expenses advisory board participation for Curium, Telix, RayzeBio, Lantheus, Cellectar, Lilly. Nathaniel Scott, Daniel Stevens, and Benjamin Fongenie are employees of Blue Earth Therapeutics Ltd. Joseph Osborne has provided consulting\/teaching services for Siemens Healthineers.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}