Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-28 @ 11:20 PM
Study NCT ID:
NCT06663904
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2024-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Abbreviated MRI for Hepatocellular Carcinoma Diagnosis
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tumor tissue specimens reveal distinct morphological features of HCC, such as abnormal cell proliferation, altered cellular architecture, and the presence of cancer nests or trabeculae. Pathologists examine these features to confirm the diagnosis, assess the tumor grade and stage, and identify any surrounding normal or precancerous liver tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 938}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2024-10-26', 'studyFirstSubmitQcDate': '2024-10-28', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with HCC', 'timeFrame': 'immediately after the surgery'}], 'secondaryOutcomes': [{'measure': 'Number of patients with non-HCC', 'timeFrame': 'immediately after pathology from postoperative or biopsy samples, or clinical diagnosis after at least 1 year without imaging indications of liver malignancy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma (HCC)']}, 'referencesModule': {'references': [{'pmid': '41042775', 'type': 'DERIVED', 'citation': 'Qin Y, Zhang J, Xu D, Zhou X, Ling Z, Li L, Zhao Q, Dong Z, Wang J, Cai HS, Li H, Zhang LG, Feng ST. Diagnosis of Hepatocellular Carcinoma Using Gadoxetic Acid-Enhanced MRI Based on LI-RADS Version 2018 and LI-RADS Modifications. Liver Int. 2025 Nov;45(11):e70366. doi: 10.1111/liv.70366.'}]}, 'descriptionModule': {'briefSummary': 'Abbreviated MRI (AMRI) could improve the diagnostic performance of hepatocellular carcinoma (HCC), but it lacks analysis in different subgroups and effective validation. The investigators aimed to compare and validate the diagnostic performance of different AMRI protocols in diagnosing early-stage HCC.', 'detailedDescription': 'This retrospective study enrolled untreated patients at risk for developing HCC who underwent gadoxetic acid-enhanced MRI from three independent cohorts from January 2020 to December 2022. Three AMRI protocols were extracted from the complete liver MRI protocol, including non-contrast (NC-AMRI), hepatobiliary phase (HBP-AMRI); and dynamic contrast-enhanced (DCE-AMRI). Two readers at each cohort independently interpreted each AMRI based on ancillary and main features from the Liver Imaging Reporting and Data System (LI-RADS) version 2018. For DCE-AMRI, two established algorithms were employed: modified LI-RADS (DCE-AMRIm) and LI-RADS v2018 (DCE-AMRIv2018). Non-HCCs were ascertained based on histologic and clinical follow-up data, while early-stage HCCs were confirmed post-operatively. Patient-level performance metrics were compared using bootstrap resampling and generalized estimating equations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive participants at risk for developing HCC (ie, liver cirrhosis of any etiologies or chronic hepatitis virus infections) who underwent gadoxetic acid-enhanced MRI between January 2020 and December 2022 and are eligible for inclusion in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no previous history of HCC treatment\n* no history of any other underlying malignancy besides HCC.\n\nExclusion Criteria:\n\n* For HCC group: (a) without preoperative MRI within 3 months; (b) without postoperative pathological confirmation; (c) liver cirrhosis without histopathologic proof or radiologic evidence; (d) the size of HCC smaller than 1cm; (e) outside of Milan Criteria; and (f) suboptimal imaging quality.\n* For non-HCC group: 1) lost follow-up, 2) insufficient follow-up period, or 3) suboptimal imaging quality.'}, 'identificationModule': {'nctId': 'NCT06663904', 'acronym': 'AMRI; LIRADS', 'briefTitle': 'Different Abbreviated MRI for Hepatocellular Carcinoma Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Multicenter Validation of Different Abbreviated MRI Protocols for Early-Stage Hepatocellular Carcinoma Diagnosis Using Main and Ancillary Features of LI-RADS', 'orgStudyIdInfo': {'id': 'SYSUFAH2021124'}, 'secondaryIdInfos': [{'id': '82271958', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}, {'id': '2024A1515012149, 2023A15150110', 'type': 'OTHER_GRANT', 'domain': 'Natural Science Foundation of Guangdong Province'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCC group', 'description': 'No previous treatments were performed before MRI examination of patients.'}, {'label': 'Non-HCC group', 'description': 'No previous treatments were performed before MRI examination of patients.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'China, Guangdong', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data generated for this study are from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical doctor', 'investigatorFullName': 'Yanjin Qin', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}