[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radioembolization\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radioembolization":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,78,108,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100629590","scout-dose-of-resin-microspheres-100629590",false,"NCT07476651","Scout Dose of Resin Microspheres","Lung Shunt Fraction Measurement With Scout Dose of Resin Yttrium-90 Microspheres for Radioembolization (LASER)","LASER","Inclusion Criteria:\n\n* Adults aged 19 years or older\n\n  * Hepatocellular carcinoma diagnosed radiologically according to the American Association for the Study of Liver Disease diagnostic criteria or diagnosed histologically, histologically diagnosed intrahepatic cholangiocarcinoma, or liver metastases\n\n    * Volume of liver not included in the treatment field is at least 30% of the total non-tumorous liver volume\n\n      * Child-Pugh class A\n\n        * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑥ Patients with lung shunt fraction ≤20% on MAA scan (planar image)\n\n          ⑦ Patients with no major organ abnormalities on blood tests performed within 2 months before treatment:\n\n          • A. Leukocytes ≥ 1,000\u002FµL and ≤ 20,000\u002FµL\n\n          • B. Hemoglobin ≥ 6.0 g\u002FdL (transfusion allowed to meet this criterion)\n\n          • C. Total bilirubin ≤ 2.0 mg\u002FdL\n\n          • D. Platelet ≥ 40,000\u002FµL\n\n          • E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants\n          * F. Aspartate transaminase (AST) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit)\n          * G. Alanine transaminase (ALT) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit)\n          * H. Creatinine ≤ 2.5 mg\u002FdL (no restriction for dialysis patients) ⑧ Patients with life expectancy of at least 3 months ⑨ For women of childbearing potential, those with negative serum pregnancy test ⑩ Patients who fully understand the content of the prospective observational study and provide written informed consent\n\nExclusion Criteria:\n\n1. Patients with biliary-enteric anastomosis or biliary stent\n2. Cases where the operator judges that even mild radiation pneumonitis could be fatal due to findings of emphysema or interstitial lung disease on chest CT\n3. Patients with a history of severe hypersensitivity reaction to iodinated contrast agents\n4. Patients with contraindications to angiography or catheter manipulation\n5. Patients with lung shunt fraction \\>20% on MAA scan (planar image)","ALL","19 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study looks at a liver cancer treatment called radioembolization and tests a new, possibly more accurate way to check if the treatment is safe for a patient's lungs.\n\nRadioembolization is a procedure where tiny beads containing a radioactive substance (yttrium-90) are injected into the arteries that feed a liver tumor. These beads lodge mainly in the tumor and deliver radiation directly to it, while sparing most of the normal liver. However, some of these beads can bypass the liver circulation and travel to the lungs. If too many reach the lungs, they can cause serious radiation damage called radiation pneumonitis.\n\nTo avoid this, doctors currently perform a \"test run\" before the real treatment. They inject a different particle called MAA into the liver artery and then do nuclear medicine scans to see how much of it goes to the lungs versus the liver. This percentage is called the lung shunt fraction. If the lung shunt is 20% or higher, radioembolization is not done; if it is between 10% and 20%, the decision depends on tumor size. The actual treatment usually happens 1-2 weeks after this test.\n\nMAA particles are similar in size to the treatment beads but not identical; some are smaller. Because of this, MAA may slightly overestimate how much of the treatment dose would really go to the lungs. Also, MAA is fully imported and has had periods of supply problems worldwide. For these reasons, there is a need for another, more accurate and more reliable way to measure lung shunt.\n\nThe LASER study tests an approach called a \"scout dose.\" In this method, doctors take a small amount of the actual treatment beads (SIR-Spheres, a resin yttrium-90 microsphere product) and inject a low radioactive dose (0.56 GBq) into the liver artery on the day of treatment. They then perform a PET\u002FCT scan and calculate how much of this scout dose went to the lungs and how much stayed in the liver. Because the scout dose uses the same type of beads as the real treatment, it may give a more accurate picture of the true lung shunt.\n\nThe study will enroll 30 adult patients who have liver tumors (liver cancer, intrahepatic cholangiocarcinoma, or liver metastases) and are already scheduled to receive radioembolization. All participants must have good liver function (Child-Pugh A), good performance status (ECOG 0-1), and an MAA-based lung shunt fraction below 20%. They also need to meet standard blood test criteria and have a life expectancy of at least three months.\n\nEach patient first undergoes the usual work-up: liver artery angiography, MAA injection, and nuclear scans, which are used to plan the treatment dose. One to two weeks later, on the treatment day, the patient has another angiogram, receives the 0.56 GBq scout dose into the liver artery, and has a scout PET\u002FCT scan while the catheter is kept in place. After calculating the lung shunt from the scout dose, the patient is brought back to the angiography room and receives the planned treatment dose, reduced by the amount already given as the scout dose. The next morning, a treatment Y90 PET\u002FCT scan is performed.\n\nThe main measurement of interest is the lung shunt fraction calculated three different ways: from the initial MAA scan, from the scout Y90 PET\u002FCT, and from the treatment Y90 PET\u002FCT. The researchers will compare how closely these three values agree. They will also look at how much radiation the tumor and normal liver receive (tumor dose, normal liver dose) and the radiation dose to the lungs, again using all three imaging methods.\n\nPatients will be followed for one year with regular clinic visits, blood tests, and CT or MRI scans according to usual care. The study will carefully record side effects such as fatigue, pain, poor appetite, and more serious problems like liver failure or radiation pneumonitis, and grade them using a standard international system (CTCAE v5.0). The researchers expect that adding the scout dose and extra scan will lengthen the procedure by about two hours and cause some discomfort from lying down longer, but they do not expect a major increase in serious risks compared with standard treatment.\n\nBy the end of the study, the team aims to show whether the scout dose method can safely and accurately replace or complement the traditional MAA-based test. If successful, this could improve the precision of radioembolization planning and offer a reliable alternative when MAA is not available",[27,28,29,30],"Radioembolization","Hepatocellular Carcinoma (HCC)","Intrahepatic Cholangiocarcinoma (ICC)","Liver Metastasis",[32,33,34,35,36,37],"lung shunt fraction","scout dose","resin microspheres","yttrium","radioembolization","selective internal radiation therapy","RECRUITING","2026-04-13",{"date":41,"type":42},"2026-04-16","ACTUAL",{"date":39,"type":42},{"date":45,"type":21},"2029-12-31",{"name":47,"class":48},"Seoul National University Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":49},"100590789","qdsa-blood-flow-measurement-in-patients-undergoing-tae-of-the-liver-100590789","NCT06971991","qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver","qDSA Blood Flow Measurement in Patients Undergoing Transarterial Embolization (TAE) of the Liver","Inclusion Criteria:\n\n* Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Patients with an acute kidney injury or stage IV or V chronic kidney disease (Cr greater than 2.4 or estimated glomerular filtration rate (eGFR) less than 30), unless anuric and on dialysis without expected return of renal function.\n* Patients with an iodinated contrast allergy who cannot be adequately premedicated to receive contrast as part of the embolization procedure.\n* Patients with a physical or psychological condition that would impair study participation.\n* The patient is judged unsuitable for study participation by the Investigator for any other reason","18 Years",{"count":59,"type":21},20,[24],"The purpose of this research is to evaluate a new technique, quantitative digital subtraction angiography (qDSA), to measure blood flow during liver embolization procedures. Liver embolization is a way of treating liver tumors by blocking blood flow to it. The qDSA technique could help doctors ensure the blood flow to the tumor is decreased by the right amount by calculating blood flow before, during, and after the procedure. Up to 20 participants will be enrolled for 1 study visit and data collection for up to 6 months.",[63,64,27],"Transarterial Embolism","Transarterial Chemoembolization",[66,27,67,68],"Quantitative digital subtraction angiography (qDSA)","TAE","TACE","2026-03-25",{"date":71,"type":42},"2026-03-30",{"date":73,"type":42},"2025-03-13",{"date":75,"type":21},"2026-12",{"name":77,"class":48},"University of Wisconsin, Madison",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":49},"100565441","phase-2-ablative-radioembolization-of-renal-cell-carcinoma-trial-100565441","NCT06642220","Ablative Radioembolization of Renal Cell Carcinoma Trial","Ablative Yttrium-90 Radioembolization Therapy for Non-Metastatic Renal Cell Carcinoma (ARRCC Trial)","ARRCC","Inclusion Criteria:\n\n* Patients willing to participate and provide written consent\n* Patients 18 years of age and older\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2\n* Biopsy confirmed RCC \\> 4.0 cm and no renal vein or IVC involvement (T1b or T2 disease)\n* Not suitable for or declining standard of care nephrectomy or partial nephrectomy\n* Adequate hepatic function, defined by the following laboratory results:\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (or ≤5 × ULN if presence of liver metastases)\n* Total bilirubin ≤3 × ULN\n* Serum albumin ≥3.0 g\u002FdL unless prothrombin time (PT) is within the normal range\n* Adequate hematologic function, defined by the following laboratory results:\n* Hemoglobin concentration ≥8.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥1000 cells\u002FµL (≥1000 cells\u002Fmm3 )\n* Platelets \\>50 × 109 \u002FL (100 × 103 \u002Fmm3 )\n* For women of childbearing potential (WOCBP):\n* Negative serum pregnancy test within 48 hours prior to the first dose of study treatment\n* Agreement to use barrier contraception and a second form of highly effective contraception (Clinical Trials Facilitation Group \\[CTFG\\] 2020) while receiving study treatment and for 7 months following their last dose of study treatment. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* Sexually active male subjects must use a condom during intercourse while receiving treatment and for at least 120 days after the last dose of the study treatment and should not father a child during this period.\n* Male study subjects whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception (CTFG 2020) while receiving 90Y and for at least 4 months following their last dose. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject.\n* Vasectomized men are also required to use a condom during intercourse, including with a male partner, to prevent delivery of the drug via seminal fluid.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease on CT or MRI\n* Severely impaired renal function (GFR ≤ 30 mL\u002Fmin\u002F1.73m²) and not on dialysis\n* Bilateral RCC without plan for definitive therapy of the contralateral lesion\n* RCC that is locally recurrent at prior surgery or ablation site (new location in same or contralateral kidney is permitted)\n* Prior or concurrent kidney radiation therapy or systemic immunotherapy\u002FTKI\n* Lung shunt with estimated lung radiation dose \\> 30 Gy for single dose or \\> 50 Gy total.\n* Planning angiogram cone beam CT from all accessible feeding arteries shows lack of perfusion to all or portions of the RCC tumour such that, in the investigator's opinion, Y-90 radioembolization would result in substantial RCC tumour being untreated or receive an inadequate dose.\n* Contraindication to arterial renal angiogram, or both CT and MRI contrast medium\n* History of severe allergy to CT contrast medium or any study product ingredients that cannot be managed medically\n* History of chronic lung disease with baseline oxygen saturation \\\u003C 90% or requiring home oxygen therapy.\n* Congestive heart failure with ejection fraction \\\u003C 40%\n* Presence of active infection, defined by the investigator as clinically significant.\n* Any chronic condition that is severe or unstable and, in the opinion of the investigator, would put the patient at unacceptable risk of adverse event related to the Y-90 radioembolization procedure. Such conditions include but are not limited to: unstable angina, congestive heart failure, interstitial lung disease, severe gastrointestinal disease with diarrhea.\n* Life expectancy \\> 1 year\n* Pregnant or breast-feeding patient",{"count":87,"type":21},16,[89],"PHASE2","Renal cell carcinoma (RCC), the most common type of kidney cancer, is typically treated with surgery; however, there is no established therapy for patients who are not surgical candidates and who have tumours greater than 4.0 cm in size. Selective internal radiation therapy (SIRT) or radioembolization using radioactive spheres containing 90-Yttrium (Y-90) is successful at treating large tumours with high doses of radiation within the liver and might be similarly effective for treating larger RCC tumours in patients, particularly those who are not surgical candidates.\n\nThis prospective study will enroll 16 participants with RCC who are not candidates for surgery and treat them with Y-90 radioembolization using a high-dose therapy to see if it is an effective cancer therapy. Primary outcome will be RCC treatment response 1 year after the Y-90 radioembolization. Additionally, the safety, tolerability, and impact on kidney function of the therapy will be monitored for all participants. Patients will be followed for a total of 5 years to evaluate long-term outcome in cancer control and safety of the treatment.",[92,27],"Renal Cell Carcinoma (RCC)",[94,36,95,96,97,98],"renal cell carcinoma","selective internal radiation therapy (SIRT)","Y-90","Transarterial radioembolization (TARE)","RCC","2025-07-15",{"date":101,"type":42},"2025-07-20",{"date":103,"type":42},"2025-07-09",{"date":105,"type":21},"2032-12-31",{"name":107,"class":48},"Derek W. Cool",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":130,"locationsCount":131},"100575558","phase-2-building-evidence-for-ablative-internal-radiation-therapy-in-localized-hcc-beyond-the-up-to-7-criteria-100575558","NCT06773845","Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria","Building Evidence for Ablative Internal Radiation Therapy Using Yttrium-90 Glass Microspheres in Localized Hepatocellular Carcinoma Beyond the Up-To-7 Criteria","BEAT-UT7","Inclusion criteria\n\n* Adult aged 19 and over\n* HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease\n* Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors \\> 7\n* Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments\n* No current or previous HCC in the untreated liver (i.e., future liver remnant \\[FLR\\])\n* FLR volume \\> 30% of total non-tumorous liver volume\n* Child-Pugh class A\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* No major organ dysfunction according to blood test performed within two months of study enrollment:\n\n  * Leukocytes ≥ 2,000\u002FµL and ≤ 15,000\u002FµL\n  * Hemoglobin ≥ 8.0 g\u002FdL (transfusion allowed to meet this criterion)\n  * Total bilirubin ≤ 2.0 mg\u002FdL\n  * Platelet ≥ 40,000\u002FµL\n  * International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants\n  * Aspartate transaminase (AST) ≤ 200 IU\u002FL (i.e., ≤ 5X upper normal limit)\n  * Alanine transaminase (ALT) ≤ 200 IU\u002FL (i.e., ≤ 5X upper normal limit)\n  * Creatinine ≤ 2.5 mg\u002FdL\n* Patients with a life expectancy of more than 3 months\n* For women of childbearing age, a negative serum pregnancy test\n* Patients who have adequately understood the clinical trial and consented in writing\n\nExclusion Criteria:\n\n* HCC with vascular invasion and\u002For bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)\n* HCC with extrahepatic spread on chest CT and abdominal CT or MRI\n* Multinodular disseminated HCC: largest tumor size \\\u003C 6 cm, or number of tumors \\> 10\n* Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA):\n\n  * Cases where the estimated lung dose exceeds 30 Gy when 350 Gy of tumor absorbed dose is administered to the tumor based on the multicompartment Medical Internal Radiation Dose (MIRD) model\n  * Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments\n  * Cases where the operator determines that there is substantial adhesion with the surrounding organs such as the bowel, making ablative radioembolization infeasible\n* Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT\n* Patients who have had active cancer within the last two years prior to the study enrollment\n* History of severe allergy of intolerance to contrast agents\n* Contraindication to angiography or selective visceral catheterization",{"count":117,"type":21},100,[89],"At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.",[28,27],[122,27,123],"Hepatocellular carcinoma","SIRT","2025-06-16",{"date":126,"type":42},"2025-06-17",{"date":128,"type":42},"2025-03-11",{"date":45,"type":21},{"name":47,"class":48},4,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":5},"100541830","multi-modal-characterisation-of-hepatocellular-carcinoma-hcc-treated-with-targeted-radionuclide-therapy-trt-prospective-interventional-multicentre-national-cohort-100541830","NCT06334965","Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort","OPERANDI-HCC","Inclusion Criteria:\n\n* Patients with HCC for whom TARE decision was made at the MDT\n* Patients ≥ 18 years of age\n* Diagnosis of HCC based on imaging (EASL guidelines) and confirmed histologically\n* At least one target lesion to be treated by radioembolisation, naïve to any previous treatment\n* Child-Pugh Class \\\u003C B8\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Life expectancy ≥ 3 months\n* Available baseline imaging (multiphasic CT), performed within 6 weeks before the beginning of TARE\n\nExclusion Criteria:\n\n* Patient with contraindication to MRI\n* Patient with contraindication to 18F-choline : potential hypersensitivity to the product or to any excipients\n* Non-adequate bone marrow, liver and renal function within 15 days prior to work-up as assessed by the following laboratory tests:\n\n  * Hemoglobin ≤ 8.0 g\u002FDl\n  * Platelet count \\\u003C 50,000\u002F mm3\n  * Total bilirubin \\> 3 mg\u002FdL (or \\> 51 µmol\u002F L).\n  * Prothrombin time ≤ 50%\n  * Glomerular Filtration Rate (GFR) \\\u003C 35 mL\u002Fmin\u002F1.73 m2\n* Infiltrating tumor more than 70% of the liver\n* Prior liver transplantation\n* Initial prescription for SIRT and concomitant systemic treatment\n* Patient refusal to give written and informed consent\n* No affiliation to a social security regimen or CMU\n* Patient under State Medical Aid\n* Known pregnancy or breastfeeding women\n* Patient deprived of freedom, subject under a legal protective measure\n* Any significant medical, psychiatric, or surgical condition that is uncontrolled and could endanger the subject's safety or limit adherence to the study's objectives and assessments",{"count":140,"type":21},180,[24],"OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI.\n\nConsidering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic PET-MRI, in patients with HCC treated with TARE.",[144,27],"Hepatocellular Carcinoma",[146,147],"transarterial radioembolization","18F Choline PET-MRI","2025-01-20",{"date":150,"type":42},"2025-01-22",{"date":152,"type":42},"2024-07-18",{"date":154,"type":21},"2029-09",{"name":156,"class":48},"Assistance Publique - Hôpitaux de Paris"]