Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04302051
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2020-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Fatty Liver with Thermo-acoustic Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique', 'timeFrame': 'one year', 'description': 'The study evaluates if the new thermo-acoustic device can accurately estimate the hepatic fat content among patients with non-alcoholic fatty liver disease to the currently approved method using MRI-PDFF scan.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver', 'timeFrame': 'One year', 'description': 'The study evaluates the number of estimation required and the appropriate anatomical site to evaluate the liver to obtain best results'}, {'measure': 'Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis.', 'timeFrame': 'One year', 'description': 'Evaluate the sensitivity of the thermo-acoustic device in diagnosis presence of hepatic steatosis among patients with MRI-PDFF finding of more than 15% hepatic steatosis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NASH', 'NAFLD', 'Non-alcoholic Fatty Liver', 'Non-Alcoholic Fatty Liver Disease', 'Non-alcoholic Steatohepatitis', 'Fatty Liver', 'Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.', 'detailedDescription': 'Patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. They will have imaging done to estimate hepatic steatosis by two modalities (MRI - PDFF and thermo-acoustic ultrasound). The estimation obtained by thermo-acoustic ultrasound will be compared with MRI results for accuracy of estimation by the thermo-acoustic ultrasound device. The study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult volunteers with diagnosed or suspected for non-alcoholic fatty liver disease will be recruited in the study. Patients who meet inclusion and exclusion criteria will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed or suspected to have non-alcoholic fatty liver disease\n* Patients 18-70 years of age\n* be able to understand and sign on written informed consent\n* able to undergo ultrasound and MRI examinations\n\nExclusion Criteria:\n\n* any metal or electronic implants including but not limited to pacemakers, clips, hips\n* known history of pregnancy or becoming pregnant during study period\n* unable to understand and sign on written informed consent\n* intolerant to ultrasound and/or MRI examinations'}, 'identificationModule': {'nctId': 'NCT04302051', 'briefTitle': 'Assessment of Fatty Liver with Thermo-acoustic Device', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging', 'orgStudyIdInfo': {'id': 'PRO00036361'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'The hepatic fat estimation will be performed on the same subjects with the use of the thermo-acoustic device and by MRI-PDFF. The data obtained from the two estimations will be compared.', 'interventionNames': ['Diagnostic Test: Thermo-acuostic image acquisition of liver', 'Diagnostic Test: MRI-PDFF estimation of hepatic fat']}], 'interventions': [{'name': 'Thermo-acuostic image acquisition of liver', 'type': 'DIAGNOSTIC_TEST', 'description': 'Estimation of hepatic fat content with thermo-acoustic device', 'armGroupLabels': ['Study Group']}, {'name': 'MRI-PDFF estimation of hepatic fat', 'type': 'DIAGNOSTIC_TEST', 'description': 'Estimation of hepatic fat content with MRI', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Achuthan Sourianarayanane, MD', 'role': 'CONTACT', 'email': 'asourianar@mcw.edu', 'phone': '4149556850'}], 'facility': 'Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'ACHUTHAN MD SOURIANARAYANANE, MD', 'role': 'CONTACT', 'email': 'asourianar@mcw.edu', 'phone': '4149556850'}], 'overallOfficials': [{'name': 'ACHUTHAN SOURIANARAYANANE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'ENDRA Life Sciences, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Achuthan Sourianarayanane', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}