[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07530172":3,"trial-entities:NCT07530172":125,"trial-summary:NCT07530172":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":77,"minimum_age":78,"maximum_age":16,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":98,"locations":101,"central_contacts":116,"overall_officials":119,"references":123,"see_also_links":124},"NCT07530172","18805","Radioembolization Versus External Radiation Therapy","RECRUITING","2029-12-31","2026-04","2026-04-15","2025-12-08","Henry Ford Health System","OTHER",true,"The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose\u002Ftotal therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.",null,[18],"Heptocellular Cancer",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE2",{"count":25,"type":26},146,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"RADIATION","Transarterial Radioembolization","The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue.",[33],"TARE",{"type":29,"name":35,"description":36,"armGroupLabels":37},"Stereotactic Body Radiation Therapy (SBRT)","The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose\u002Ftotal therapy adjusted as needed for safety.",[38],"SBRT",[40],{"measure":41,"description":42,"timeFrame":43},"Rate of re-treatment over 12 months","Rate of re-treatment of the index lesion over 12 months","From enrollment to 12 months following the end of treatment",[45,49,52,55,58,61,65,67,70,74],{"measure":46,"description":47,"timeFrame":48},"Laboratory toxicities CBC","Laboratory CBC (includes WBC (k\u002FuL), RBC (M\u002FuL), and Platelets (K\u002FuL)","From enrollment to 24 months post treatment",{"measure":50,"description":51,"timeFrame":48},"Laboratory toxicities CMP","Laboratory CMP (includes Sodium (mmol\u002FL), Creatine (mg\u002FdL), Total Bilirubin (mg\u002FdL), ALP (IU\u002FL), AST\u002FSGOT (IU\u002FL), ALT\u002FSGPT (IU\u002FL), Serum Albumin (g\u002Fdl), INR (unitless), AFP (ng\u002FmL)",{"measure":53,"description":54,"timeFrame":48},"Laboratory toxicities INR","Laboratory INR (unitless)",{"measure":56,"description":57,"timeFrame":48},"Laboratory toxicities AFP","Laboratory AFP (ng\u002FmL)",{"measure":59,"description":60,"timeFrame":48},"Clinical toxicities","Clinical toxicities measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Scale of 1 to 5 with 5 being the worst outcome.",{"measure":62,"description":63,"timeFrame":64},"Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) version 4.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.","Change in patient reported outcomes","From enrollment to 1, 3, and 6 months post treatment",{"measure":66,"description":63,"timeFrame":64},"Change in COST: A FACIT Measure of Financial Toxicity (FACIT-COST) version 2.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.",{"measure":68,"description":69,"timeFrame":48},"Disease Free Survival","DFS at 2 years",{"measure":71,"description":72,"timeFrame":73},"Local Control","LC at 6 months after completion of treatment using LIRADS on multiphase CT or MR","From enrollment to 6 months post treatment",{"measure":75,"description":76,"timeFrame":48},"Overall Survival","OS at 2 years","ALL","18 Years",false,{"inclusion":81,"exclusion":91,"raw_text":97},[82,83,84,85,86,87,88,89,90],"Ability to provide written informed consent and HIPAA authorization","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female, aged ≥ 18 years at time of informed consent","No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board","Childs-Pugh score ≤ 8","ECOG performance status ≤2","Adequate organ function defined as:","serum bilirubin \\\u003C 4.0 mg\u002FdL ,","albumin \\> 2 g\u002FdL",[92,93,94,95,96],"Any prior SBRT or radioembolization to the target tumor","Macrovascular invasion","Planned or recommended systemic therapy as consolidation","Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration.","Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy","Inclusion Criteria:\n\n* Ability to provide written informed consent and HIPAA authorization\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥ 18 years at time of informed consent\n* No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board\n* Childs-Pugh score ≤ 8\n* ECOG performance status ≤2\n* Adequate organ function defined as:\n* serum bilirubin \\\u003C 4.0 mg\u002FdL ,\n* albumin \\> 2 g\u002FdL\n\nExclusion Criteria:\n\n* Any prior SBRT or radioembolization to the target tumor\n* Macrovascular invasion\n* Planned or recommended systemic therapy as consolidation\n* Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration.\n* Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy",[99,100],"ADULT","OLDER_ADULT",[102],{"facility":12,"status":7,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":113},"Detroit","Michigan","48202","United States",[108],{"name":109,"role":110,"phone":111,"email":112},"Marissa Gilbert","CONTACT","3135568422","mgilber6@hfhs.org",{"lat":114,"lon":115},42.33143,-83.04575,[117],{"name":109,"role":110,"phone":118,"email":112},"313-556-8422",[120],{"name":121,"affiliation":12,"role":122},"Reena Salgia, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Hepatocellular Carcinoma",[],{"nct_id":4,"found":14,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is a single-site, randomized Phase 2 study comparing two radiation treatments. It plans to enroll 146 participants.","completed","Phase 2 Study of Radioembolization vs. External Radiation for Liver Cancer","This study is comparing two radiation treatments for hepatocellular carcinoma (a type of liver cancer): Transarterial Radioembolization (TARE) and Stereotactic Body Radiation Therapy (SBRT). TARE involves delivering Yttrium-90 directly to the tumor through an artery. SBRT uses external radiation given in a few sessions. The study aims to see which treatment leads to fewer re-treatments of the tumor over 12 months. You may be able to join if you are 18 or older, have up to 3 liver cancer lesions, and meet certain health criteria. The study is currently unclear on its recruitment status and plans to enroll 146 participants.","Participants will be followed for 12 months after the end of their treatment.",100,"You would undergo either Transarterial Radioembolization (TARE) or Stereotactic Body Radiation Therapy (SBRT). The study will follow you for 12 months after treatment ends.","Not stated in the trial record.",[30,35],"v2"]