Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-02 @ 10:30 AM
Study NCT ID:
NCT03516695
Status:
TERMINATED
Last Update Posted:
2021-04-21
First Post:
2018-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "due to Sponsor's ongoing and upcoming projects and overall research priorities", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2018-03-22', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting', 'timeFrame': '12 months follow up post last TheraSphere® treatment', 'description': 'Tumor response to TheraSphere® treatment will be assessed using Modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 depending on tumor type.'}], 'secondaryOutcomes': [{'measure': 'Serious adverse events', 'timeFrame': '6 months follow up post last TheraSphere® treatment', 'description': 'Serious adverse events assessed as related or possibly related to TheraSphere®.'}, {'measure': 'Adverse events of interest', 'timeFrame': '6 months follow up post last TheraSphere® treatment', 'description': 'Specific adverse events assessed as related or possibly related to TheraSphere®, comprising of any of the following events: fatigue, pain, nausea, ascites, lymphopenia, hyperbilirubinemia, hypoalbuminemia.'}, {'measure': 'TheraSphere® Dosimetry in the subgroup of HCC participants', 'timeFrame': 'From up to 30 days until the date of TheraSphere® Treatment and Baseline', 'description': 'Dose absorbed to normal tissue and tumor, using the pre TheraSphere® 99mTc-MAA SPECT/CT, will be examined and compared to post TheraSphere® Y90 PET/CT (or equivalent in Asia) using the Simplicit90Y™ software.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Registry', 'Liver Cancers', 'HCC', 'Dosimetry', 'Simplicit90Y™', 'TheraSphere®'], 'conditions': ['Liver Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.btgplc.com', 'label': 'Sponsor Website'}]}, 'descriptionModule': {'briefSummary': 'This study is a non-interventional, observational, prospective, and global participant data registry. The study will collect effectiveness and safety data from approximately 1000 participants with liver cancers treated with TheraSphere® in a real-life setting from multiple centers globally. The absorbed dose to tumor and normal tissue will be calculated using the Simplicit90Y™ software in the subgroup of hepatocellular carcinoma (HCC) participants.', 'detailedDescription': 'This study is a non-interventional, observational, prospective and global participant data registry.\n\nApproximately 1000 participants with liver cancers who are treated with TheraSphere® will be enrolled.\n\nData regarding participant and treatment characteristics (TheraSphere® and other anti-cancer treatments) will be collected within a 12-month period post TheraSphere® administration to:\n\n* Assess treatment effectiveness and safety in a real-life administration setting\n* Identify prognostic and predictive factors for liver cancer participants receiving TheraSphere® treatment\n\nData for dosimetry determination will be collected on approximately 300 HCC participants to assess:\n\n* Technetium-99m Macroaggregated albumin (99mTc-MAA) normal tissue and tumor Absorbed Dose using pre-procedural Single Proton Emission Computed Tomography/ Computed Tomography (SPECT/CT)\n* Yttrium-90 and isotopes (Y90) normal tissue and tumor Absorbed Dose using post-procedural PET/CT (or equivalent for Asia) scans'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with liver cancer for whom treatment with TheraSphere® has been prescribed and who meet all study eligibility criteria will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is ≥ 18 years of age\n2. Participant has confirmed liver cancer\n3. Participant is able to provide informed consent according to local requirements/law\n4. Participant has a life expectancy of ≥ 3 months\n5. Participant is scheduled to receive TheraSphere® treatment\n\nExclusion Criteria:\n\n1. Participant who has previously received Y90 microspheres\n2. Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment'}, 'identificationModule': {'nctId': 'NCT03516695', 'acronym': 'READ90Y', 'briefTitle': 'RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry', 'orgStudyIdInfo': {'id': 'BTG-007509-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TheraSphere®', 'type': 'DEVICE', 'description': 'Intra-arterial Yttrium-90 glass microspheres'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Allina Health System Virginia Piper Cancer Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Regents of the University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'T6G 2C8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Riccardo Lencioni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami (previously known affiliation)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biocompatibles UK Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}