Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
Study NCT ID:
NCT06703450
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-28
First Post:
2024-11-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Guerbet Liver Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver Stiffness by MR Elastography', 'timeFrame': 'during procedure (MRI)', 'description': 'Liver stiffness that is quantitively measured by MR Elastography and correlated with grade of tissue fibrosis from histopathology. Min and Max Scale: 0-20 kilopascals (continuous variable). Higher score indicates poorer health outcomes.'}], 'secondaryOutcomes': [{'measure': 'Total Liver Flow', 'timeFrame': 'during procedure (MRI)', 'description': 'Liver Perfusion (DCE MRI) to measure Total liver flow (continuous variable) Max and Min: 0-500 mL/minute per 100g tissue'}, {'measure': 'Arterial Fraction of flow', 'timeFrame': 'during procedure (MRI)', 'description': "Arterial Fraction of flow - measures and compares the blood flow on both sides of a blockage in the heart's coronary artery to see how much the blockage is affecting blood flow."}, {'measure': 'Portal Venous Fraction of flow', 'timeFrame': 'during procedure (MRI)', 'description': "Portal Venous Fraction of flow - measures and compares the blood flow on both sides of a blockage in the heart's coronary artery to see how much the blockage is affecting blood flow."}, {'measure': 'Distribution volume of contrast', 'timeFrame': 'during procedure (MRI)', 'description': 'Distribution volume of contrast agent'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Dysfunction-associated Steatotic Liver Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the value of liver dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and texture analysis post gadopiclenol for liver fibrosis staging, in comparison with MR elastography, T1 mapping, ultrasound elastography and blood tests in 50 initial patients with metabolic dysfunction-associated steatohepatitis (MASH).', 'detailedDescription': 'Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as nonalcoholic fatty liver disease or NAFLD) is characterized by the accumulation of excess fat in the liver, ranging from mild forms like non-alcoholic fatty liver (NAFL) to more severe stages such as metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis or NASH) with associated inflammation, ballooning, fibrosis, and cirrhosis. The severity of MASH and increasing fibrosis stages is associated with higher morbidity and mortality rates. The study will compare dynamic contrast-enhanced (DCE)-MRI measurements of perfusion using gadopiclenol for diagnosis of liver fibrosis to MR elastography and transient elastography, T1 mapping, ultrasound elastography and blood tests, using histopathology as the reference in patients with MASH. In this study, the value of DCE-MRI and texture analysis using gadopiclenol, a new macrocyclic, non-ionic, extracellular contrast agent with high relaxivity will also be assessed which provides, at a lower dose, better contrast-to-noise ratio than gadoterate, gadobenate, and gadobutrol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing MRI for management of chronic liver disease, such as MASH/NAFLD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected MASLD (F0-F4) with clinically indicated percutaneous or transjugular liver biopsy within 6 months of MRI (before or after MRI).\n* Both genders.\n* Age \\> 18 years.\n* Any racial/ethnic background.\n\nExclusion criteria:\n\n* Previous history or current diagnosis of HCC or decompensation.\n* Contraindications for MRI, including\n\n * Medically unstable\n * Intracranial clips\n * Metal implants\n * Suspected or confirmed metal in eyes\n * Cardiac pacemaker, implanted defibrillator, other implanted electronic device\n * Pregnancy: Pregnancy tests will be offered to women of childbearing age at no cost\n * Severe claustrophobia'}, 'identificationModule': {'nctId': 'NCT06703450', 'briefTitle': 'Guerbet Liver Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Noninvasive Diagnosis of Liver Fibrosis With Gadopiclenol DCE-MRI in Metabolic Dysfunction-associated Steatohepatitis (MASH)', 'orgStudyIdInfo': {'id': 'GCO 23-0855'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with liver disease', 'description': 'Participants with liver disease for diagnosis of liver fibrosis to have DCE-MRI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sara Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guerbet', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiology Physician', 'investigatorFullName': 'Sara Lewis', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}