MRI biomarkers to detect NASH in adults with fatty liver
Exploratory Study of MRI Biomarkers of NASH
NA · University Hospital, Angers · NCT06626074
This project will try MRI measurements to see if they can detect NASH in adults with fatty liver who are already scheduled for a liver biopsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers (other gov) |
| Locations | 1 site (Angers, France) |
| Trial ID | NCT06626074 on ClinicalTrials.gov |
What this trial studies
This single-center exploratory project will use quantitative MRI sequences to look for imaging biomarkers that correlate with histologic NASH in adults with metabolic steatosis. Participants will be drawn from the Angers SNIFF cohort and will undergo MRI within three months of a clinically indicated liver biopsy. Imaging measures (fat quantification, stiffness-related and other quantitative MRI parameters) will be compared to biopsy results to identify signatures of inflammation and early fibrosis. The goal is to determine whether MRI can noninvasively indicate NASH and reduce reliance on biopsy.
Who should consider this trial
Good fit: Adults in the Angers SNIFF cohort with suspected NASH who are scheduled for a diagnostic liver biopsy and can safely undergo MRI are the ideal candidates.
Not a fit: People who cannot have an MRI (for example due to metal implants or severe claustrophobia), pregnant or breastfeeding women, those with more than a three-month gap between biopsy and MRI, or those excluded for legal or insurance reasons are unlikely to benefit.
Why it matters
Potential benefit: If successful, MRI biomarkers could allow diagnosis of NASH without liver biopsy, reducing invasive procedures and their risks.
How similar studies have performed: Previous studies have shown MRI reliably quantifies liver fat and stiffness, but no MRI biomarker has yet been proven to diagnose NASH (inflammation/ballooning) without biopsy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient included in the SNIFF cohort of the Angers hospital where there is a suspicion of NASH requiring a biopsy for which an MRI is requested by a hepatologist as part of the initial assessment of the disease. * Adult patient * Free, informed and express (oral) consent of the patient to participate in the study Exclusion Criteria: * Contraindication to MRI * Time between the establishment of the Steatosis/NASH status and the MRI greater than 3 months * Pregnant, parturient and breastfeeding woman * Person deprived of liberty by judicial or administrative decision * Person under compulsion to psychiatric care * Person subject to a legal protection measure * Person not affiliated or not covered by a social security scheme.
Where this trial is running
Angers, France
- University Hospital, Angers — Angers, France, France (RECRUITING)
Study contacts
- Principal investigator: Anita PAISANT, MD — University Hospital, Angers
- Study coordinator: Anita PAISANT, MD
- Email: anita.paisant@chu-angers.fr
- Phone: 0241353637
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-alcoholic Fatty Liver Disease NAFLD