Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2026-03-16 @ 9:54 PM
Study NCT ID:
NCT02461212
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2015-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2015-06-01', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between HepaFat-Scan and pathology based assessment of steatosis', 'timeFrame': '12 months', 'description': 'Correlation of histologic steatosis to HepaFat-Scan measurement.'}, {'measure': 'Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and computerized steatosis', 'timeFrame': '12 months', 'description': 'The percent of total steatosis by MRS and computerized steatosis (computer-assisted pixel count algorithm) will be plotted and Pearson correlation coefficient will be calculated to explore their relationship.'}, {'measure': 'Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment', 'timeFrame': '12 months', 'description': 'The percent steatosis from the MRS and grade of pathology of assessment will be plotted and compared to categorization using HepaFat-Scan.'}, {'measure': 'Repeatability of HepaFat-Scan', 'timeFrame': '12 months', 'description': 'Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HepaFat-Scan', 'Liver Disease', 'Pediatrics'], 'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in a MRI) can accurately detect the amount of fat in the liver.', 'detailedDescription': 'The leading cause of liver disease for both adults and children in the US is nonalcoholic fatty liver disease (NAFLD), an obesity-related liver disease closely associated with the metabolic syndrome. NAFLD increases the risk of liver disease but also increases risk of type II diabetes, cardiovascular disease (CVD) and the metabolic syndrome. Invasive liver biopsy has been considered the best diagnostic tool for confirming NAFLD. This study will establish magnetic resonance imaging (MRI) / magnetic resonance spectroscopy (MRS) as a quantitative noninvasive "virtual biopsy" and benefit the health of children with liver diseases by decreasing risk and improving diagnosis. Specifically, in NAFLD, this fat quantification protocol will be broadly useful in future research studies, including therapies for NAFLD as well as for patient diagnosis and follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Boys and girls age 7-18 years\n* Scheduled for a clinically indicated liver biopsy\n* Able to undergo MRI without sedation\n* Written informed consent from parent or legal guardian\n* Written informed assent from the child when indicated by age\n\nExclusion Criteria:\n\n* Renal disease with a creatinine \\> 2 or requiring dialysis\n* Metal, braces or other implanted devices not compatible with MRI\n* Not willing to try to hold still for an un-sedated MRI\n* Pregnancy\n* Failure to give consent or assent'}, 'identificationModule': {'nctId': 'NCT02461212', 'briefTitle': 'Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth', 'orgStudyIdInfo': {'id': 'IRB00078470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liver MRI', 'description': 'Liver MRI imaging will be performed on subjects undergoing a liver biopsy', 'interventionNames': ['Procedure: Magnetic Resonance Imaging (MRI)']}, {'type': 'EXPERIMENTAL', 'label': 'Liver MRI repositioned', 'description': 'Liver MRI imaging will be performed on subjects undergoing a liver biopsy and then they will be repositioned and will repeat the MRI', 'interventionNames': ['Procedure: Magnetic Resonance Imaging (MRI)']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'PROCEDURE', 'description': 'A MRI scan which will include magnetic resonance spectroscopy (MRS) of the liver to determine hepatic triglyceride content, a hepafat scan to measure volume fraction of fat in liver tissue, and a MRI for detection of liver fibrosis. The scan will last approximately 15 minutes.', 'armGroupLabels': ['Liver MRI', 'Liver MRI repositioned']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta at Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Miriam B Vos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Resonance Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Miriam Vos, MD', 'investigatorAffiliation': 'Emory University'}}}}