Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT06030232
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2023-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2024-07-29', 'unreleaseDate': '2024-09-16'}, {'resetDate': '2024-11-15', 'releaseDate': '2024-09-16'}, {'resetDate': '2025-01-03', 'releaseDate': '2024-11-19'}, {'resetDate': '2025-01-30', 'releaseDate': '2025-01-05'}], 'estimatedResultsFirstSubmitDate': '2024-07-29'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effective tumor dose and safe healthy liver dose', 'timeFrame': '3th month after treatment', 'description': 'Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis.'}], 'secondaryOutcomes': [{'measure': 'dose (in Gy) -response and dose (in Gy)-toxicity relationships', 'timeFrame': '6th month after treatment', 'description': 'Investigate dose-response and dose-toxicity relationships after transarterial radioembolization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Transarterial Radioembolization']}, 'descriptionModule': {'briefSummary': 'Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of 90Y glass microspheres in the treatment of HCC, literature data on the treatment of metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the recent EANM guideline variable healthy liver doses are recommended for patients with mCRC with an effective tumor dose recommendation based on a study with limited number of patients.\n\nPrimary objectives; Investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with metastatic colorectal cancer (mCRC) treated using Y90 glass microspheres in lobar or segmental fashion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years old\n* histopathologically proven colorectal cancer diagnosis\n* treated with radioembolization for liver metastases with Y90 glass microspheres in lobar or segmental fashion\n* have follow-up data at least 6 months after radioembolization\n\nExclusion Criteria:\n\n* no PET-CT, CT or MR of the liver within last 6 weeks prior to radioembolization.\n\nNo PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality Previous local treatment or surgery for the liver'}, 'identificationModule': {'nctId': 'NCT06030232', 'acronym': 'TACOME', 'briefTitle': 'Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver', 'orgStudyIdInfo': {'id': 'TACOME-TR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation group', 'description': 'Patients who received radioembolization for colorectal cancer liver metastases', 'interventionNames': ['Device: Therasphere']}], 'interventions': [{'name': 'Therasphere', 'type': 'DEVICE', 'description': 'Transarterial radioembolization', 'armGroupLabels': ['Observation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University Medical School', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Medical School', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe Univeristy Medical School', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Capa Medical School', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Cerrahpasa Medical School', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Medical School', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Yeditepe University Medical School', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University Medical School', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asc. Prof. of Nuclear Medicine, MD, FEBNM', 'investigatorFullName': 'Cigdem Soydal', 'investigatorAffiliation': 'Ankara University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-29', 'type': 'RELEASE'}, {'date': '2024-09-16', 'type': 'UNRELEASE'}, {'date': '2024-09-16', 'type': 'RELEASE'}, {'date': '2024-11-15', 'type': 'RESET'}, {'date': '2024-11-19', 'type': 'RELEASE'}, {'date': '2025-01-03', 'type': 'RESET'}, {'date': '2025-01-05', 'type': 'RELEASE'}, {'date': '2025-01-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Cigdem Soydal, Asc. Prof. of Nuclear Medicine, MD, FEBNM, Ankara University'}}}}