Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05690451
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2022-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-contrast Abbreviated MRI for Secondary Surveillance of HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-22', 'studyFirstSubmitDate': '2022-12-28', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy per patient', 'timeFrame': 'Within 6 months from the study completion', 'description': 'Accuracy for detection of recurrent HCC per patient'}], 'secondaryOutcomes': [{'measure': 'Specificity per patient', 'timeFrame': 'Within 6 months from the study completion', 'description': 'Specificity for detection of recurrent HCC per patient'}, {'measure': 'Sensitivity per patient', 'timeFrame': 'Within 6 months from the study completion', 'description': 'Sensitivity for detection of recurrent HCC per patient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secondary surveillance of hepatocellular carcinoma', 'Contrast enhanced liver CT', 'non-contrast abbreviated MRI'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.', 'detailedDescription': 'This study was designed as a prospective single-arm intra-individual comparison multicenter study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent curative treatment for HCC including surgical resection or local ablation and have a more than a two-year disease-free period, needing continuous surveillance for the development of HCC will be candidates for this study.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 20-year old and 85-year old\n* Patients with a history of curative treatment for HCC including surgical resection or local ablation\n* No recurrence after curative treatment of HCC for more than two years\n* Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)\n\nExclusion Criteria:\n\n* Estimated GFR less than 60\n* Previous history of severe allergic reaction to the iodinated contrast agent\n* Patients with claustrophobia who can't undergo MR examination\n* Patients having cochlear implants or cardiac pacemaker"}, 'identificationModule': {'nctId': 'NCT05690451', 'briefTitle': 'Non-contrast Abbreviated MRI for Secondary Surveillance of HCC', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study', 'orgStudyIdInfo': {'id': 'H-2106-183-1230'}, 'secondaryIdInfos': [{'id': 'KCT0006395', 'type': 'REGISTRY', 'domain': 'https://cris.nih.go.kr/'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'non-contrast abbreviated MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Liver MRI without contrast injection. The following sequences will be obtained from all of the participants.\n\n* Axial heavily and regular T2 WI\n* precontrast fat-suppressed T1 WI\n* Diffusion-weighted image using b-value of 0, 50 or 400, and 800 or 1000'}, {'name': 'Contrast enhanced liver CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Liver CT with iodine contrast injection This test will be served as a standard diagnostic test. The following phases will be obtained\n\n* precontast, arterial phase, portal venous phase and delayed phase'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam', 'state': 'Korea (the Republic Of)', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Korea (the Republic Of)', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dong Ho Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data (IPD) of this study will be available for reasonable requests after approval of IRB'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Dong Ho Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}