Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT05296434
Status:
UNKNOWN
Last Update Posted:
2022-03-25
First Post:
2022-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delta Radiomics for Liver Function Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between delta radiomics parameter and ICG test in assessment of liver function', 'timeFrame': 'within 3 days', 'description': 'MRI and ICG tests performed within 3 days apart'}], 'secondaryOutcomes': [{'measure': 'Correlation between delta radiomics parameter and serum biochemical tests in assessment of liver function', 'timeFrame': 'with 3 days', 'description': 'MRI and blood biochemical tests performed within 3 days apart'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver function', 'magnetic resonance imaging', 'radiomics', 'chronic liver disease', 'quantitative assement'], 'conditions': ['Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility and efficacy of delta radiomics-derived index based on Gd-EOB-DTPA enhanced MRI as a new imaging biomarker for the quantitative assessment of liver function.', 'detailedDescription': 'Delta radiomics is a novel concept proposed on the basis of radiomics. It can be used to evaluate the dynamic changes of imaging features in the time dimension, reflecting functional information of the tissue.\n\nIn clinical practice, liver function can be evaluated by gadoxate enhanced MRI by measuring signal intensity. Most often, simple visual assessment is performed, but quantitative measurements are also done. Theoretically, liver function should also be possible to quantify by using delta radiomics, ie by subtracting MR imaging features obtained in the earlier phase from the latter phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers and patients with different degrees of liver function impairment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years old, no gender limit.\n* Patients with chronic liver disease and different degrees of liver damage (Child-Pugh A, B and C) and healthy controls.\n* No history of liver-related surgery (except for cholecystectomy).\n* No cardiopulmonary diseases or other diseases which may impair liver function.\n* Agree to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Alcoholic hepatitis, non-alcoholic fatty liver disease, or autoimmune hepatitis.\n* Liver tumors or metastasis or other extraheptic tumor.\n* Splenectomy or other cases where the spleen is absent.\n* Chronic kidney disease, renal damage.\n* Allergy to contrast agents or other conditions that cannot undergo Gd-EOB-DTPA enhanced MRI exam.'}, 'identificationModule': {'nctId': 'NCT05296434', 'briefTitle': 'Delta Radiomics for Liver Function Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Delta Radiomics Based on Gd-EOB-DTPA-enhanced MRI for Quantitative Evaluation of Liver Function', 'orgStudyIdInfo': {'id': '2021-KY-105-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Healthy volunteers undergoing MRI exam, ICG test and blood biochemical tests'}, {'label': 'Child-Pugh A Group', 'description': 'Composed of patients with liver function of Child-Pugh A grade undergoing MRI exam, ICG test and blood biochemical tests'}, {'label': 'Child-Pugh B Group', 'description': 'Composed of patients with liver function of Child-Pugh B grade undergoing MRI exam,ICG test and blood biochemical tests'}, {'label': 'Child-Pugh C Group', 'description': 'Composed of patients with liver function of Child-Pugh C grade undergoing MRI exam'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510280', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Yingfang Fan, MD,PhD', 'role': 'CONTACT', 'email': 'fanxifan@smu.edu.cn', 'phone': '86-13189097816'}], 'facility': 'The First Department of Hepatobiliary Surgery, Zhujiang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yingfang Fan, MD,PhD', 'role': 'CONTACT', 'email': 'fanxifan@smu.edu.cn', 'phone': '86-13189097816'}, {'name': 'Xiaojun Hu, MD', 'role': 'CONTACT', 'email': 'huxj2016@163.com', 'phone': '86-13925156062'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yingfang Fan', 'investigatorAffiliation': 'Zhujiang Hospital'}}}}