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Exploratory Study of MRI Biomarkers of NASH

Study acronym: IRM-NASH
StatusRecruiting
PhaseNot applicable
Started2025-09-05
View on ClinicalTrials.gov ↗

Amendment history

2026-06-12
minor
Study Status, Oversight, Study Design, Contacts/Locations v4
Enrollment target60→110
Study sites1→2
2025-09-24
minor
Study Status, IPDSharing v3
Re-verified, no change to tracked fields
2025-09-15
notable
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2026-12-01→2027-09-05
Completion date2026-12-02→2027-09-06
Start date2024-11-29→2025-09-05
Study sitesdetails revised at 1 of 1 site
2024-11-29
notable
Not Yet Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Start dateestimated 2024-12-01→confirmed 2024-11-29
Study sitescontacts updated at 1 of 1 site
2024-10-01
minor
Original filing
Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries. NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI. Nonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications. Currently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy. There is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.
Trial Details
NCT Number NCT06626074
Lead Sponsor University Hospital, Angers
Collaborators: Angers University
Conditions Non-alcoholic Fatty Liver Disease NAFLD
Enrollment 110 participants
Start Date 2025-09-05
Primary Completion 2027-09-05 (estimated)
Study Completion 2027-09-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-16