Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT06706856
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Ultrasound to Assess Steatotic Liver Disease in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma, blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development and Evaluation of models for liver fat estimation.', 'timeFrame': '5 years', 'description': 'We plan to develop and evaluate models for estimating liver fat fraction and classifying the presence or absence of steatotic liver disease using QUS data.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['MASLD', 'steatosis', 'quantitative ultrasound', 'quantitative MRI', 'fat fraction', 'PDFF'], 'conditions': ['MASLD', 'MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease']}, 'descriptionModule': {'briefSummary': 'This research study is being conducted to find out more about advanced ultrasound techniques to non-invasively evaluate liver disease in children. The investigators are developing advanced techniques for analyzing ultrasound data and images of the liver, and they will compare it to other established methods used to evaluate the liver, including liver MRI.\n\nThe investigators plan to develop and test the advanced analysis techniques using conventional full-size ultrasound machines and, if possible, small handheld devices.\n\nOur goals are:\n\n* To assess the accuracy of the advanced ultrasound analysis techniques in children\n* To implement and assess these advanced technique on small handheld ultrasound devices, if possible', 'detailedDescription': 'Our broad long-term objective is to improve the health of children with metabolic dysfunction-associated steatotic liver disease (MASLD), a condition characterized by accumulation of fat in liver cells, by developing and validating accurate, precise, practical, and widely available tools to detect, measure, and monitor liver fat.\n\nOur study aims to develop advanced quantitative ultrasound (QUS) analysis models for use with full-size US and, if possible, inexpensive point-of-care ultrasound (POCUS) systems in children at risk for MASLD to estimate liver fat fraction and classify presence/absence of fatty liver. We anticipate the models will incorporate technical innovations to improve QUS accuracy and efficiency. To develop and test these models, we plan to enroll 120 children who will undergo ultrasound exams using either full-size or POCUS devices. We plan to compare the performance of our QUS models with liver MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children being evaluated for MASLD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 9 to 18 years\n* Presence of risk factors for having MASLD\n* Ability and willingness of participant or legal guardian/parent to give written informed consent\n* Participant is willing to give written assent\n* Able and willing to undergo all study procedures\n\nExclusion Criteria:\n\n* Known liver disease other than MASLD\n* Pregnant or trying to become pregnant\n* Inability to undergo an MR study: weight exceeding scanner table limit, waist circumference \\> 140 cm, claustrophobie, and/or metal implants.'}, 'identificationModule': {'nctId': 'NCT06706856', 'briefTitle': 'Quantitative Ultrasound to Assess Steatotic Liver Disease in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Quantitative Ultrasound to Assess Steatotic Liver Disease in Children', 'orgStudyIdInfo': {'id': '809669'}, 'secondaryIdInfos': [{'id': '1R01DK135951-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK135951-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'This is a single arm study in which all participants undergo the same research procedures.', 'interventionNames': ['Diagnostic Test: MR exam', 'Diagnostic Test: US exam', 'Other: Blood draw', 'Other: Physical measurements', 'Other: Questionnaires']}], 'interventions': [{'name': 'MR exam', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.', 'armGroupLabels': ['Cohort']}, {'name': 'US exam', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo an abdominal ultrasound (US) examination using a full-size US system. Some participants may undergo a point-of-care abdominal US exam with a handheld US system, if possible.', 'armGroupLabels': ['Cohort']}, {'name': 'Blood draw', 'type': 'OTHER', 'description': 'Participants will undergo a blood draw of approximately 25 mL volume.', 'armGroupLabels': ['Cohort']}, {'name': 'Physical measurements', 'type': 'OTHER', 'description': 'Participants will have their height, weight and waist circumference measured. Vital signs including respiratory frequency, heart rate, temperature, and blood pressure will be measured.', 'armGroupLabels': ['Cohort']}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Participants will be asked to fill out questionnaires to collect information about their prescribed medications, demographics, medical and surgical histories, prior laboratory results, physical activity and lifestyle measures, and potential alcohol intake (AUDIT questionnaire).', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Alba', 'role': 'CONTACT', 'email': 'amalba@health.ucsd.edu', 'phone': '619-543-5226'}], 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Amy Alba', 'role': 'CONTACT', 'email': 'amalba@health.ucsd.edu', 'phone': '619-543-5228'}, {'name': 'Gage Tanzman', 'role': 'CONTACT', 'email': 'g1tanzman@health.ucsd.edu'}], 'overallOfficials': [{'name': 'Jeffrey B Schwimmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}, {'name': 'Claude B Sirlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'url': 'https://library.ucsd.edu/dc', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Start date: 7/1/2025 (anticipated) End date: On or after 7/1/2040 (anticipated)', 'ipdSharing': 'YES', 'description': 'Deidentified study data and metadata except imaging data will be deposited in the UC San Diego Library Digital Collections Data Repository.', 'accessCriteria': 'The data repository (containing deidentified study data and metadata except imaging data) will be made public and will be available from the UC San Diego Digital Collections Data Repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Virginia Polytechnic Institute and State University', 'class': 'OTHER'}, {'name': 'GE Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology', 'investigatorFullName': 'Claude Sirlin', 'investigatorAffiliation': 'University of California, San Diego'}}}}