Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT05302258
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2022-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Attenuation Imaging in Hepatic Steatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of attenuation imaging', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The diagnostic performance of attenuation imaging in US in the detection of hepatic steatosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Steatosis', 'Obesity, Childhood', 'Ultrasonography']}, 'descriptionModule': {'briefSummary': 'For obese and normal-weight children, the investigators assess the diagnostic performance of attenuation imaging (ATI) in the detection of hepatic steatosis in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese and normal-weight children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of 85th percentile or less\n\nExclusion Criteria:\n\n* congenital anomaly including heart, intestine, kidney\n* acute hepatitis\n* congenital hepatic anomaly'}, 'identificationModule': {'nctId': 'NCT05302258', 'briefTitle': 'Attenuation Imaging in Hepatic Steatosis', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Kangnam Sacred Heart Hospital'}, 'officialTitle': 'Noninvasive Assessment of Hepatic Steatosis by Using Attenuation Imaging in Children', 'orgStudyIdInfo': {'id': 'ATI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obesity', 'description': 'BMI of 95 th percentile or more', 'interventionNames': ['Diagnostic Test: Attenuation imaging in ultrasonography']}, {'label': 'Normal weight', 'description': 'BMI of 85 th percentile or less', 'interventionNames': ['Diagnostic Test: Attenuation imaging in ultrasonography']}], 'interventions': [{'name': 'Attenuation imaging in ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Attenuation imaging in ultrasonography', 'armGroupLabels': ['Normal weight', 'Obesity']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Kangnam Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}