Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-29 @ 10:56 PM
Study NCT ID:
NCT06616103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-27
First Post:
2024-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 111}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2024-09-24', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis', 'timeFrame': 'At the time of enrollment', 'description': 'diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis using MRI-PDFF and MR elastography as reference standards'}], 'secondaryOutcomes': [{'measure': 'Consistency between MRI-derived body composition data and CT-derived data', 'timeFrame': 'At the time of enrollment', 'description': 'Consistency between MRI-derived body composition data and CT-derived data using automated 3D organ segmentation algorithm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B', 'Steatosis of Liver', 'Fibrosis and Cirrhosis of Liver']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis B who follow up at Seoul National University Hospital having no history of hepatic malignancies', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic hepatitis B\n* no chronic liver disease other than chronic hepatitis B\n* Body mass index \\>= 23\n\nExclusion Criteria:\n\n* pregnant women\n* unable to perform MRI examinations due to claustrophobia or metallic foreign body\n* suspicious hepatic malignancy on previous imaging studies\n* history of local treatment for hepatic lesions\n* history of surgery or catheter insertion of liver or spleen'}, 'identificationModule': {'nctId': 'NCT06616103', 'briefTitle': 'Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Utility of Quantitative Imaging Parameters from Deep Learning-based CT Segmentation in Assessing Hepatic Steatosis and Fibrosis in Chronic Hepatitis B: a Prospective Study Using MRI As the Reference Standard', 'orgStudyIdInfo': {'id': 'CHB prospective MEDIP'}, 'secondaryIdInfos': [{'id': 'RS-2023-00253896', 'type': 'OTHER_GRANT', 'domain': 'National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'computerized tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'noncontrast abdominal CT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Jeongin Yoo, M.D.', 'role': 'CONTACT', 'email': 'jeongin527@snu.ac.kr', 'phone': '+82-220723107'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'Jeongin Yoo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}