Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-03 @ 12:39 AM
Study NCT ID:
NCT04800094
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2021-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-23', 'mcpReleaseN': 4, 'releaseDate': '2024-09-03'}, {'resetDate': '2024-11-05', 'mcpReleaseN': 5, 'releaseDate': '2024-10-15'}, {'resetDate': '2024-12-17', 'mcpReleaseN': 6, 'releaseDate': '2024-11-21'}, {'resetDate': '2025-10-19', 'mcpReleaseN': 7, 'releaseDate': '2025-09-29'}, {'resetDate': '2025-12-03', 'mcpReleaseN': 8, 'releaseDate': '2025-11-14'}], 'estimatedResultsFirstSubmitDate': '2024-09-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.'}], 'secondaryOutcomes': [{'measure': 'Inter-operator variability in measurements of ultrasound biomarkers for liver fat', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'Inter-operator variability will be assessed by comparing the ultrasound biomarkers measured from each subject by two different operators who have received standardized training. Following biomarkers will be measured:\n\n* Hepatorenal Index\n* Acoustic attenuation'}, {'measure': 'Ultrasound biomarker measurement failure rate', 'timeFrame': 'Intra-procedural (1 day)', 'description': 'The ultrasound biomarker measurement failure rate will be assessed by measuring the percentage of subjects in whom measurements cannot be made due to technical limitations.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Liver Fat Quantification', 'Ultrasound', 'Liver Disease', 'Digestive System Disease'], 'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Non-Alcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD). The primary objective of this clinical study is to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat percentage obtained from MRI Proton Density Fat Fraction (MRI-PDFF) measurements. All subjects enrolled in this study will undergo one investigational abdominal ultrasound examination using the Philips EPIQ Ultrasound System and one MRI PDFF examination according to the clinical standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects at least 5 years old up through and including 21 years old who are able to provide informed consent to participate or have a legal representative/parent/legal guardian who is able to provide informed consent for the subject to participate.\n* Subjects must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination.\n\nIn addition, at least one of the following criteria must also be met:\n\n* Overweight or obese (BMI-for-age ≥ 85th percentile).\n* Diagnosed with Type 2 diabetes per standard clinical guidelines.\n* Diagnosed with hypercholesterolemia per standard clinical guidelines.\n* Diagnosed with or clinically suspected of having NAFLD/NASH based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing.\n\nExclusion Criteria:\n\n* History of moderate/heavy/binge alcohol consumption exceeding NIAAA guidelines.\n* Evidence of hepatotoxicity or cirrhosis in the clinical judgment of the investigator.\n* History of chronic liver disease other than NAFLD (e.g., viral, cholestatic, or autoimmune).\n* Use of drugs associated with hepatic steatosis:\n\n * Amiodarone\n * Methotrexate\n * Nucleoside reverse transcriptase inhibitors (didanosine, stavudine)\n * Valproic acid\n * Dexamethasone\n * Tamoxifen\n * 5-FU-based adjuvant chemotherapy\n * Apo-B inhibitors (mipomersen, lomitapide)\n * Tetracycline exceeding 2 g/day\n * Acetylsalicylic acid exceeding 150 mg/kg'}, 'identificationModule': {'nctId': 'NCT04800094', 'briefTitle': 'Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Pilot Study of On-Cart Liver Fat Quantification (LFQ) Feature to Assess Correlation With Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) Results in a Pediatric Population', 'orgStudyIdInfo': {'id': 'US-GIS-10983'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational Ultrasound Imaging for Liver Fat Quantification', 'interventionNames': ['Device: Investigational Liver Fat Quantification Software']}], 'interventions': [{'name': 'Investigational Liver Fat Quantification Software', 'type': 'DEVICE', 'description': 'All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.', 'armGroupLabels': ['Investigational Ultrasound Imaging for Liver Fat Quantification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Smita S Bailey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Phoenix Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}