Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-02 @ 1:51 PM
Study NCT ID:
NCT05264051
Status:
RECRUITING
Last Update Posted:
2024-11-14
First Post:
2022-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waitlist Mortality', 'timeFrame': 'Measured up to 10 years out from enrollment', 'description': 'Death prior to liver transplant or delisting from enrollment in the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to study the muscle assessment score (MAsS, utilizing MRI, as an objective measure of frailty and muscle composition to serve as a predictor of morbidity and mortality in patients with liver disease.', 'detailedDescription': 'Prospective study of patients seen at the Univ. of Chicago Medical Center hospital and ambulatory clinics. The assessment of the MAsS score will require an additional 8-10 minutes in the MRI for each patient already undergoing MRI exam.\n\nFour groups of pts. who are already scheduled for MRI for routine clinical purposes will be evaluated.\n\n1. Pts. hospitalized with acute hepatic decompensation for whom MRI is otherwise indicated for clinical evaluation.\n2. Pts. with hepatobiliary neoplasia\n3. Pts.undergoing transjugular portosystemic shunt (TIPS) placement\n4. Pts. with chronic liver disease undergoing magnetic resonance elastography for routine monitoring'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pts. hospitalized with acute hepatic decompensation Pts. with hepatobiliary neoplasia Pts. undergoing TIPS placement Pts. with chroinic liver disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are already scheduled for an MRI for routine clinical purposes will be evaluated\n\nExclusion Criteria:\n\n* \\<18 yrs. of age'}, 'identificationModule': {'nctId': 'NCT05264051', 'briefTitle': 'MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease', 'orgStudyIdInfo': {'id': 'IRB21-0900'}}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Newsome', 'role': 'CONTACT', 'email': 'mnewsome1@bsd.uchicago.edu', 'phone': '773-702-2788'}, {'name': 'Omar Jamal, MD', 'role': 'CONTACT', 'email': 'Omar.Jamil@uchospitals.edu', 'phone': '773-702-0309'}, {'name': 'Michael Charlton, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Omar Jamil, MD', 'role': 'CONTACT', 'email': 'Omar.Jamil@uchospitals.edu', 'phone': '847-373-2360'}, {'name': 'Maria Newsome', 'role': 'CONTACT', 'email': 'mnewsome1@bsd.uchicago.edu', 'phone': '773-702-2788'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}