Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-21 @ 11:08 PM
Study NCT ID:
NCT03162302
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2017-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Fat and Iron Quantification MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proton Density Fat Fraction (0 to 100%) in the liver of each subject', 'timeFrame': '2 years', 'description': 'MRI based measurement of liver fat content using proton density fat fraction'}, {'measure': 'Transverse Magnetization Relaxation Rate R2* (1/sec) in the liver of each subject', 'timeFrame': '2 years', 'description': 'MRI based measurement of R2\\* is associated with underlying liver iron content'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'magnetic resonance imaging', 'fat quantification', 'iron quantification'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to develop and evaluate novel magnetic resonance imaging (MRI) protocols for studying the structure and function of the human body using 1.5 Tesla and 3.0 Tesla MRI scanners with or without the use of an MRI contrast agent.', 'detailedDescription': 'This study will include on-going technical development work for the non-invasive diagnosis of liver fat or iron accumulation and other abnormalities. MRI is a non-invasive imaging technique with no known side effects. The study will utilize imaging equipment that is used routinely in numerous hospitals and clinics around the world.\n\nThe project seeks to address optimization of the imaging methodology at 1.5 Tesla and 3.0 Tesla in the liver and abdomen in order to improve clinical evaluation and care of future patients. Non contrast MRI studies will be performed in normal healthy subjects. In addition, the study will include subjects with confirmed disease or who have suspicion for disease, and are undergoing contrast or non-contrast MR imaging as part of their standard of care. Up to sixty-five (65) male or female subjects eighteen years of age and older will be studied in total (number includes healthy subjects and non-healthy subjects).\n\nCurrently, clinical MRI exams are of adequate spatial and temporal resolution, sufficient quantitative accuracy, and acceptable exam duration, but improvements in each of these areas would benefit the care of future patients. For example, improvements in spatial and temporal resolution may confer greater conspicuity of disease and shortening the exam duration can be expected to improve patient acceptance and minimize motion artifacts. The study explores innovative ideas about ways to improve MRI exams to have impact in all three of these areas.\n\nCurrent MRI techniques for fat and iron quantification in the liver and abdomen are challenged by respiratory and organ motion. As a result, imaging parameters (coverage, resolution, etc) and TE (echo time) selection for fat/iron quantification are compromised to accommodate a short breath-held 2D or 3D scan, which can still be affected by motion artifacts and even unachievable for patients with limited breath-holding capability. Therefore, the study aims to achieve robust free-breathing fat/iron quantification in the liver and abdomen using innovative MRI techniques and algorithms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll healthy volunteers over age 18 and clinical patients who are scheduled to undergo a clinically indicated MRI of the abdomen or who are willing to undergo a separate research scan.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy Volunteers:\n\n * Healthy subjects 18 years or older\n2. Clinical Patients:\n\n * Patients who are 18 years or older and who are scheduled for a routine clinically indicated MRI exam at University of California Los Angeles\n\nExclusion Criteria:\n\n1. Healthy Volunteers:\n\n * Age less than 18 years\n * Subject with the following devices/implants/conditions will be excluded:\n\n 1. cardiac pacemakers\n 2. defibrillators\n 3. cochlear implants\n 4. intraocular metallic foreign bodies\n 5. intracranial aneurysm clips\n 6. claustrophobia\n * Subjects will be excluded if they have a history of severe renal disease (Creatinine level \\>2.5 mg/dl or Glomerular Filtration Rate \\<15 ml/minute/1.73m2 ) or allergy to MRI contrast agents ("dyes"). Healthy volunteers will not be studied with these agents.\n * Pregnant subjects will not be enrolled. Although there is no data to suggest that MRI is harmful to the fetus, this study is limited to non-pregnant subjects.\n2. Clinical Patients:\n\n * Age less than 18 years\n * Subject with the following devices/implants/conditions will be excluded:\n\n 1. cardiac pacemakers\n 2. defibrillators\n 3. cochlear implants\n 4. intraocular metallic foreign bodies\n 5. intracranial aneurysm clips\n 6. claustrophobia\n * Subjects will be excluded if they have a history of severe renal disease (Creatinine level \\>2.5 mg/dl or Glomerular Filtration Rate \\<15 ml/minute/1.73m2 ) or allergy to MRI contrast agents ("dyes").\n * Pregnant subjects will not be enrolled. Although there is no data to suggest that MRI is harmful to the fetus, this application is limited to non-pregnant subjects.'}, 'identificationModule': {'nctId': 'NCT03162302', 'briefTitle': 'Liver Fat and Iron Quantification MRI', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Free-Breathing Liver Fat and Iron Quantification Using 3D Stack-of-Radial MRI', 'orgStudyIdInfo': {'id': '17-000276'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Subjects', 'description': 'Healthy volunteers will undergo 60 minute non-contrast enhanced Magnetic Resonance Imaging (MRI) of the abdomen using novel imaging sequences.', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging (MRI)']}, {'label': 'Clinical Patients', 'description': 'Patients in whom an MRI is indicated for their disease condition will undergo the clinical scan, followed by up to 30 minutes non-contrast enhanced Magnetic Resonance Imaging (MRI) of the abdomen using novel imaging sequences. Clinical patients may also elect to undergo a research only scan of approximately one hour.', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging (MRI)']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['MR'], 'description': 'Magnetic resonance imaging (MRI) is a non-invasive imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body.', 'armGroupLabels': ['Clinical Patients', 'Healthy Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Holden H Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siemens Corporation, Corporate Technology', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor-in-Residence', 'investigatorFullName': 'Holden H. Wu, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}