Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-28 @ 11:46 AM
Study NCT ID:
NCT05953961
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2023-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D034141', 'term': 'Hypoalbuminemia'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007019', 'term': 'Hypoproteinemia'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Progression', 'timeFrame': '1-year', 'description': 'Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm'}], 'secondaryOutcomes': [{'measure': 'Target Response Evaluation Criteria in Solid Tumors modified for HCC', 'timeFrame': '60 - 120 days post-treatment', 'description': 'Durable target tumor response rate'}, {'measure': 'Time to Retreatment', 'timeFrame': '1 year', 'description': 'Duration of time following the first cycle treatment until the targeted tumor requires additional treatment'}, {'measure': 'Duration of Response', 'timeFrame': '1 year', 'description': 'Duration of time after first cycle treatment the target tumor continues to respond to treatment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Yttrium-90', 'Hypoalbuminemia'], 'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.', 'detailedDescription': 'This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin \\< 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.\n\nThe study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines\n* Eastern Cooperative Oncology Group score 0 - 1\n* Child-Pugh A - B\n* Bilirubin \\< 2.5 mg/dL\n* Creatinine \\< 2.0 mg/dL\n* No prior liver-directed therapy or systemic therapy for HCC\n* Solitary, unresectable HCC ≤ 3cm\n* Albumin level \\< 3.4 g/dL at HCC diagnosis\n* Tumor anatomical location and angiosome amendable to MWA and 90Y\n\nExclusion Criteria:\n\n* Pregnant women\n* Concurrent malignancy'}, 'identificationModule': {'nctId': 'NCT05953961', 'acronym': 'REALM', 'briefTitle': '90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia', 'orgStudyIdInfo': {'id': '2023.090'}, 'secondaryIdInfos': [{'id': 'Sponsored Research Agreement', 'type': 'OTHER_GRANT', 'domain': 'Boston Scientific'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Therasphere Transarterial Radioembolization', 'description': 'Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.', 'interventionNames': ['Device: Therasphere 90Y']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Microwave Ablation', 'description': 'Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin \\> 5mm.', 'interventionNames': ['Device: Microwave Ablation']}], 'interventions': [{'name': 'Therasphere 90Y', 'type': 'DEVICE', 'description': 'Transarterial Radioembolization', 'armGroupLabels': ['Therasphere Transarterial Radioembolization']}, {'name': 'Microwave Ablation', 'type': 'DEVICE', 'description': 'Microwave Ablation', 'armGroupLabels': ['Microwave Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ken Bode', 'role': 'CONTACT', 'email': 'ken.bode@ochsner.org'}], 'facility': 'Ochsner Main Campus', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Ken Bode', 'role': 'CONTACT', 'email': 'ken.bode@ochsner.org', 'phone': '5048421936'}, {'name': 'Amy Riehm', 'role': 'CONTACT', 'email': 'amyriehm@ochsner.org', 'phone': '5047039065'}], 'overallOfficials': [{'name': 'Ari Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ochsner Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}