Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-02 @ 4:54 AM
Study NCT ID:
NCT03342703
Status:
COMPLETED
Last Update Posted:
2021-04-22
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'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_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-21', 'studyFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discriminatory value (AUC) of US in assessing liver stiffness', 'timeFrame': 'an estimated time of 30 minutes', 'description': 'Discriminatory value (the ability of the test to diagnose disease from healthy) will be calculated using nonparametric receiver operating characteristic (ROC) curve analysis. Sensitivity (i.e. true positive rate: the ability of a test to correctly identify patients with the disease being investigated) is plotted on the y axis and 1-specificity (i.e. false positive rate: the test incorrectly identifies patients who do not have the disease being investigated as having the disease) will be plotted on the x-axis. Cutoff points of US liver stiffness values will be chosen to create the graph of sensitivity versus 1-Specificity, i.e. the ROC curve, and the area under the curve (AUC) is used to determine how well US discriminates patients with liver stiffness from patients without liver stiffness.\n\nThe closer the AUC gets to 1, the more discriminatory the test. An AUC=0.5 is a test that is right 50% of the time, and is no better than flipping a coin.'}, {'measure': 'Discriminatory value (AUC) of US in assessing liver fat content', 'timeFrame': 'an estimated average of 30 minutes', 'description': 'Discriminatory value (the ability of the test to diagnose disease from healthy) will be calculated using nonparametric receiver operating characteristic (ROC) curve analysis. Sensitivity (i.e. true positive rate: the ability of a test to correctly identify patients with the disease being investigated) is plotted on the y axis and 1-specificity (i.e. false positive rate: the test incorrectly identifies patients who do not have the disease being investigated as having the disease) will be plotted on the x-axis. Cutoff points of US liver fat content values will be chosen to create the graph of sensitivity versus 1-specificity, i.e. the ROC curve, and the area under the curve (AUC) is used to determine how well US discriminates patients with liver fat content from patients without liver fat content.\n\nThe closer the AUC gets to 1, the more discriminatory the test. An AUC=0.5 is a test that is right 50% of the time, and is no better than flipping a coin.'}], 'secondaryOutcomes': [{'measure': 'US Elastography Stiffness', 'timeFrame': 'an estimated average of 30 minutes', 'description': "MRI tissue stiffness is reported in shear modulus (S), while US uses Young's modulus (Y). Since Y = 2\\*(1+m)\\*S, where m is the Poisson's ratio for the material, and since that ratio is between 0.49 and 0.50 for tissue, the US measurements should be three times that of the MRI ones. In particular, treating the MRI measurements as the reference, theory predicts a linear relationship:\n\nY = 0 + 3\\*S\n\nwhich can be tested with a linear regression model. The most straightforward means is by calculating the expected Young's modulus values for US from the MR measurements, and regressing them on the observed US measurements.\n\nBoth US and MRI values are given below."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Liver Steatoses', 'Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The investigators will assess the ability of ultrasound (US) to measure liver stiffness (cirrhosis) and liver fat content (steatosis).', 'detailedDescription': 'Non-invasive monitoring of liver fibrosis using magnetic resonance imaging (MRI) can help determine which patients will most benefit from interventional therapies to help reverse the condition. Similarly, quantitative assessment of liver fat content using MRI can assist physicians in identifying patients at risk for hepatic steatohepatitis.\n\nDue to the widespread dissemination of US machines and their relative lower cost compared to other imaging modalities, e.g. MRI, the ability of US to assess these parameters widens diagnostic availability.\n\nPatients who have undergone an MRI exam to assess liver stiffness (cirrhosis) and/or liver fat content (steatosis) will be asked to undergo an US exam to assess the same parameters. The cirrhosis and steatosis measurements obtained from both exams will be compared. If US-based measurements of liver stiffness and/or liver fat content are shown to be reproducible and accurate when compared to MRI values (will be used as the gold standard), US may become the first-line diagnostic test for these liver conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have or are scheduled to undergo a routine clinical MRI at Stanford that included assessment of liver stiffness or liver fat content will be identified using the radiology schedule.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. participants who have a clinical indication for a standard of care MRI exam that included assessment of the liver\n2. participant is at least 18 years of age\n\nExclusion Criteria:\n\n1. Participants unable to take part in the decision making process on whether to consent to the trial\n2. Patients with previous chemoembolization or other focal liver therapies to the liver (\\* NOTE: for liver transplant patients, this criterion is only applicable to the transplanted liver)'}, 'identificationModule': {'nctId': 'NCT03342703', 'briefTitle': 'Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI', 'orgStudyIdInfo': {'id': '38649'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Liver Fibrosis Measurement', 'description': 'Group1: Patients will undergo an Ultrasound to correlate fibrosis measurements obtained using standard-of-care MRI.', 'interventionNames': ['Diagnostic Test: Ultrasound']}, {'label': 'Patients with Liver Steatosis Measurement', 'description': 'Group 2: Patients will undergo an Ultrasound to correlate steatosis measurements obtained using standard-of-care MRI.', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['US elastography', 'US fat quantification'], 'description': 'Patients will undergo a standard liver US protocol for approximately 15 minutes.', 'armGroupLabels': ['Patients with Liver Fibrosis Measurement', 'Patients with Liver Steatosis Measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospital', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Aya Kamaya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Andreas Loening, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Aya Kamaya', 'investigatorAffiliation': 'Stanford University'}}}}