{"preliminary_commentary":{"by_channel":{"x_thread":6},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[],"indication":"locally advanced hepatocellular carcinoma","name":"DOSISPHERE-01","nct_id":"NCT02582034","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=dosisphere-01-nct02582034. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Standard Internal Radiation Therapy : Dose of radiation delivered to the tumoral volume is fixed : 120 Gray (GY)","label":"Standard dosimetry","type":"ACTIVE_COMPARATOR"},{"description":"Optimized Internal Radiation Therapy : Dose of radiation absorbed by the tumor is \\> 205 GY, if possible 250 or 300 Gy.","label":"Optimized dosimetry","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2018-12","type":"ACTUAL"},"conditions":["Adenoma, Liver Cell"],"enrollment":{"count":56,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Optimized Internal Radiation Therapy","otherNames":[],"type":"RADIATION"},{"name":"Standard Internal Radiation Therapy","otherNames":[],"type":"RADIATION"}],"last_update":"2019-01-31","lead_sponsor":"Center Eugene Marquis","official_title":"Selective Internal Radiation Therapy for Hepatocellular Carcinomas With Yttrium-90 Loaded Microspheres: Optimized Dosimetry Versus Standard Dosimetry","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2018-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"The primary endpoint is to compare the response rate of the treated lesion at the first radioembolization, evaluated using European Association for the Study of the Liver (EASL) criteria of yttrium-90 marked glass microspheres SIRT","timeFrame":"3 months after treatment administration"}],"references":[{"citation":"Garin E, Tselikas L, Guiu B, Chalaye J, Rolland Y, de Baere T, Assenat E, Tacher V, Palard X, Deandreis D, Mariano-Goulart D, Amaddeo G, Boudjema K, Hollebecque A, Meerun MA, Regnault H, Vibert E, Campillo-Gimenez B, Edeline J. Long-Term Overall Survival After Selective Internal Radiation Therapy for Locally Advanced Hepatocellular Carcinomas: Updated Analysis of DOSISPHERE-01 Trial. J Nucl Med. 2024 Feb 1;65(2):264-269. doi: 10.2967/jnumed.123.266211.","pmid":"38212068","type":"DERIVED"},{"citation":"Garin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7.","pmid":"33166497","type":"DERIVED"}],"start_date":{"date":"2015-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry","url":"https://clinicaltrials.gov/study/NCT02582034"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/dosisphere-01-nct02582034"}