[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04518748":3,"trial-entities:NCT04518748":140,"trial-summary:NCT04518748":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":63,"secondary_outcomes":74,"sex":89,"minimum_age":90,"maximum_age":15,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":117,"locations":120,"central_contacts":129,"overall_officials":130,"references":134,"see_also_links":139},"NCT04518748","UMCC 2020.052","Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.","A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.","ACTIVE_NOT_RECRUITING","2028-11","2026-07","2026-07-31","2020-09-16","University of Michigan Rogel Cancer Center","OTHER",null,"This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.","Selective Internal Radiation Therapy (SIRT) is a technique where radiation is internally delivered to a tumor. In SIRT, small radioactive beads are deposited in the liver through a large blood vessel (hepatic artery). SIRT that uses the radioactive material Yttrium-90 is called Y-90 SIRT.\n\nStereotactic Body Radiation Therapy (SBRT) is a technique where radiation is externally delivered to a tumor. In SBRT, a machine produces a beam of radiation that targets the tumor from outside the body.\n\nAfter receiving Y-90 SIRT, participants will be evaluated to estimate how much radiation was absorbed by their tumors during Y-90 SIRT. Y-90 PET-CT imaging will be used to help plan SBRT, which will target areas of tumors that did not receive as much radiation as expected during Y-90 SIRT.\n\nUpdated to add 5 patients to enrollment goal to achieve desired number of evaluable patients\n\nSince patients treated with Y-90 for any liver malignancy can benefit from the Y-90+SBRT combined treatment approach we have decided to open up the protocol to all eligible patients and not HCC alone.",[19],"Liver Malignancy",[21,22,23],"Ytrium-90 (Y-90)","Selective Internal Radiation Therapy (SIRT)","Stereotactic Body Radiation Therapy (SBRT)","INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},70,"ACTUAL",[32,40,47,54,59],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Yttrium-90","Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)",[37],"Y-90 SIRT followed by SBRT",[39],"Y-90",{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DEVICE","Selective Internal Radiation Therapy","SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres",[37],[46],"SIRT",{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"RADIATION","Stereotactic Body Radiation Therapy","3-5 fractions over 1-2 weeks, after Y-90 SIRT",[37],[53],"SBRT",{"type":55,"name":56,"description":57,"armGroupLabels":58},"DIAGNOSTIC_TEST","PET\u002FCT","Within 3 hours of completing Y-90 SIRT",[37],{"type":41,"name":60,"description":61,"armGroupLabels":62},"Therasphere","Glass microspheres containing Y-90, administered at day 0 by SIRT",[37],[64,68,71],{"measure":65,"description":66,"timeFrame":67},"Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline","The primary safety endpoint is the binary indicator for a CTP increase of 2 or more points within 6 months and relative to pre-SBRT baseline. An increase of 2 or more points indicates clinically significant liver decompensation.","Up to 6 months after SBRT",{"measure":69,"description":70,"timeFrame":67},"Incidence of toxicities of grade 3 or higher","A secondary safety endpoint is grade 3+ toxicity within 6 months relative to pre-SBRT baseline. Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.",{"measure":72,"description":73,"timeFrame":67},"Number of patients with a change in albumin + bilirubin (ALBI) level of >= 0.5","A secondary safety endpoint is the binary indicator for an increase in ALBI within 6 months relative to pre-SBRT baseline of 0.5 or greater.",[75,79,82,85],{"measure":76,"description":77,"timeFrame":78},"Freedom from local progression (FFLP) at the lesion level","FFLP at the lesion level is defined as the time from SIRT to progression of a SBRT-treated lesion. Progression is defined based on RECIST and mRECIST criteria.","Until progression or last surveillance scan at approximately 24 months after SBRT",{"measure":80,"description":81,"timeFrame":78},"Freedom from local progression (FFLP) at patient level","FFLP at the patient level is defined as the time from SIRT to progression of the treated lesions including those not targeted by SBRT. Progression is defined based on RECIST v1.1and mRECIST criteria.",{"measure":83,"description":84,"timeFrame":67},"Response rate","Response rate defined per RECIST v1.1 and mRECIST criteria and categorized as follows: progressive disease or stable disease = non-responder, partial response or complete response = responder.",{"measure":86,"description":87,"timeFrame":88},"Overall survival","Overall survival will be calculated as the time from Y-90 SIRT treatment to death from any cause, or until patient's last follow-up visit, or until study stops.","Until death from any cause, or until patient's last follow-up visit, or until study stops; up to approximately 5 years.","ALL","18 Years",false,{"inclusion":93,"exclusion":103,"raw_text":116},[94,95,96,97,98,99,100,101,102],"Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following:","Biopsy proven hepatocellular carcinoma (HCC); or","A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria.","Patients must not have known untreated or progressive disease outside of the liver","At least one lesion \\>2 cm diameter or 4 cc volume","Patients must have a life expectancy of at least 6 months.","Patients must be 18 years of age or older","All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment.","Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.",[104,105,106,107,108,109,110,111,112,113,114,115],"Inability to lie still for imaging studies (e.g. PET\u002FCT)","Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction.","Patients with known allergy or contraindication to intravenous iodinated contrast agents","Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium)","Contraindication to Theraspheres","Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques","Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs.","Hepatic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis;","Bilirubin \\>2.0 at baseline","Occlusion of the main portal vein","Contraindication to radiation therapy","Note: Patients who have an increase in bilirubin \\>1.0 from the time of Y90 to SBRT or his\u002Fher bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.","Inclusion Criteria:\n\n* Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following:\n\n  * Biopsy proven hepatocellular carcinoma (HCC); or\n  * A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria.\n\nMetastatic liver cancer is defined as having:\n\no pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease\n\n* Patients must not have known untreated or progressive disease outside of the liver\n* At least one lesion \\>2 cm diameter or 4 cc volume\n* Patients must have a life expectancy of at least 6 months.\n* Patients must be 18 years of age or older\n* All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment.\n* Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.\n\nExclusion Criteria:\n\n* Inability to lie still for imaging studies (e.g. PET\u002FCT)\n* Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction.\n* Patients with known allergy or contraindication to intravenous iodinated contrast agents\n* Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium)\n* Contraindication to Theraspheres\n\n  * Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques\n  * Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs.\n  * Hepatic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis;\n  * Bilirubin \\>2.0 at baseline\n  * Occlusion of the main portal vein\n* Contraindication to radiation therapy\n* Note: Patients who have an increase in bilirubin \\>1.0 from the time of Y90 to SBRT or his\u002Fher bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.",[118,119],"ADULT","OLDER_ADULT",[121],{"facility":13,"city":122,"state":123,"zip":124,"country":125,"geoPoint":126},"Ann Arbor","Michigan","48109","United States",{"lat":127,"lon":128},42.27756,-83.74088,[],[131],{"name":132,"affiliation":13,"role":133},"Kyle Cuneo, MD","PRINCIPAL_INVESTIGATOR",[135],{"pmid":136,"type":137,"citation":138},"38960710","DERIVED","Lu Z, Polan DF, Wei L, Aryal MP, Fitzpatrick K, Wang C, Cuneo KC, Evans JR, Roseland ME, Gemmete JJ, Christensen JA, Kapoor BS, Mikell JK, Cao Y, Mok GSP, Dewaraja YK. PET\u002FCT-Based Absorbed Dose Maps in 90Y Selective Internal Radiation Therapy Correlate with Spatial Changes in Liver Function Derived from Dynamic MRI. J Nucl Med. 2024 Aug 1;65(8):1224-1230. doi: 10.2967\u002Fjnumed.124.267421.",[],{"nct_id":4,"conditions":141,"biomarkers":144},[142,143],"Hepatocellular Carcinoma","Liver Carcinoma",[],{"nct_id":4,"found":146,"summary":147,"prompt_version":157},true,{"design":148,"status":149,"heading":150,"summary":151,"follow_up":152,"word_count":153,"commitments":154,"compensation":155,"drugs_mentioned":156},"This is an interventional study with a planned enrollment of 70 participants. It is not specified if it is randomized or blinded.","completed","Combined Y-90 SIRT and SBRT for Liver Cancer","This study is looking at a new way to treat liver cancer by combining two established radiation therapies: Yttrium-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT uses tiny radioactive beads delivered directly to the liver tumor, while SBRT uses external radiation beams. The study aims to see how safe and effective this combined approach is. You may be able to join if you are 18 or older and have unresectable hepatocellular carcinoma or metastatic liver cancer. Researchers will measure side effects and changes in your liver health for up to six months after SBRT. The study is currently recruiting 70 participants.","Your liver health and side effects will be monitored for up to 6 months after SBRT.",108,"You will receive Y-90 SIRT on day 0, followed by a PET\u002FCT scan within 3 hours. Then, you will receive SBRT over 3-5 fractions during 1-2 weeks.","Not stated in the trial record.",[34,42,49],"v2"]