{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T17:51:03Z","timestamp":1790704263905,"version":"4.1.0"},"reference-count":28,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2023,4,11]],"date-time":"2023-04-11T00:00:00Z","timestamp":1681171200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Cancer Institute Eug\u00e8ne Marquis of Rennes"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background: Despite the wide development of 90Y-loaded microspheres, 188Re-labeled lipiodol is still being used for radioembolization of hepatocellular carcinoma (HCC). However, the use of this latter compound is limited by in vivo instability. This study sought to evaluate the safety, bio-distribution, and response to 188Re-SSS lipiodol, a new and more stable compound. Method: Lip-Re-01 was an activity-escalation Phase 1 study involving HCC patients progressing after sorafenib. The primary endpoint was safety based on Common Terminology Criteria for Adverse Events (AEs) of Grade \u22653 within 2 months. Secondary endpoints included bio-distribution assessed by scintigraphy quantification from 1 to 72 h, tumor to non-tumor uptake ratio (T\/NT), as well as blood, urine and feces collection over 72 h, dosimetry, and response evaluation (mRECIST). Results: Overall, 14 heavily pre-treated HCC patients were treated using a whole liver approach. The mean injected activity was 1.5 \u00b1 0.4 GBq for activity Level 1 (n = 6), 3.6 \u00b1 0.3 GBq for Level 2 (n = 6), and 5.0 \u00b1 0.4 GBq for Level 3 (n = 2). Safety was acceptable with only 1\/6 of Level 1 and 1\/6 of Level 2 patients experiencing limiting toxicity (one liver failure; one lung disease). The study was prematurely discontinued unrelated to clinical outcomes. Uptake occurred in the tumor, liver, and lungs, and only sometimes in the bladder. The T\/NT ratio was high with a mean of 24.9 \u00b1 23.4. Cumulative urinary elimination and fecal eliminations at 72 h were very low, 4.8 \u00b1 3.2% and 0.7 \u00b1 0.8%, respectively. Partial response occurred in 21% of patients (0% in the first activity level; 37.5% in the others). Conclusion: The high in vivo stability of 188Re-SSS lipiodol was confirmed, resulting in encouraging responses for a Phase 1 study. As the 3.6 GBq activity proved to be safe, it will be used in a future Phase 2 study.<\/jats:p>","DOI":"10.3390\/cancers15082245","type":"journal-article","created":{"date-parts":[[2023,4,12]],"date-time":"2023-04-12T01:35:08Z","timestamp":1681263308000},"page":"2245","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["188Re-SSS Lipiodol Radioembolization in HCC Patients: Results of a Phase 1 Trial (Lip-Re-01 Study)"],"prefix":"10.3390","volume":"15","author":[{"given":"Etienne","family":"Garin","sequence":"first","affiliation":[{"name":"Department of Nuclear Medicine, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"},{"name":"Campus Sant\u00e9, University of Rennes, F-35042 Rennes, France"},{"name":"INSERM, INRAE, Nutrition M\u00e9tabolismes et Cancer U1317, University of Rennes, F-35033 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Palard","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"},{"name":"Campus Sant\u00e9, University of Rennes, F-35042 Rennes, France"},{"name":"CLCC Eug\u00e8ne Marquis, Inserm, LTSI-UMR 1099, University of Rennes, F-35000 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Rolland","sequence":"additional","affiliation":[{"name":"CLCC Eug\u00e8ne Marquis, Inserm, LTSI-UMR 1099, University of Rennes, F-35000 Rennes, France"},{"name":"Department of Radiology, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Le Sourd","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9860-5451","authenticated-orcid":false,"given":"Nicolas","family":"Lepareur","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"},{"name":"INSERM, INRAE, Nutrition M\u00e9tabolismes et Cancer U1317, University of Rennes, F-35033 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Val\u00e9rie","family":"Ardisson","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christelle","family":"Bouvry","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Laffont","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2329-5265","authenticated-orcid":false,"given":"Boris","family":"Campillo-Gimenez","sequence":"additional","affiliation":[{"name":"CLCC Eug\u00e8ne Marquis, Inserm, LTSI-UMR 1099, University of Rennes, F-35000 Rennes, France"},{"name":"Department of Clinical Research, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Bellissant","sequence":"additional","affiliation":[{"name":"Campus Sant\u00e9, University of Rennes, F-35042 Rennes, France"},{"name":"INSERM CIC 1414 (Clinical Investigation Center), F-35033 Rennes, France"},{"name":"Department of Clinical and Biological Pharmacology and Pharmacovigilance, Pharmaco-Epidemiology and Drug Information Center, Rennes University Hospital, F-35033 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8289-7741","authenticated-orcid":false,"given":"Julien","family":"Edeline","sequence":"additional","affiliation":[{"name":"Campus Sant\u00e9, University of Rennes, F-35042 Rennes, France"},{"name":"Department of Medical Oncology, Cancer Institute Eug\u00e8ne Marquis, F-35042 Rennes, France"},{"name":"INSERM, COSS (Chemistry Oncogenesis Stress Signaling)\u2014UMR_S 1242, University of Rennes, F-35042 Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,4,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"E359","DOI":"10.1002\/ijc.29210","article-title":"Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012","volume":"136","author":"Ferlay","year":"2015","journal-title":"Int. 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