Exploratory Study of MRI Biomarkers of NASH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quantitative MRI sequences.
- Who it may be relevant to
- Registry conditions: Non-alcoholic Fatty Liver Disease NAFLD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Quantitative MRI sequences
additional sequences during MRI
Primary outcome measures
- Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis [Time frame: the outcome measurment is performed once during MRI]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- University Hospital, Angers — Angers
- CHU de Rennes — Rennes
Identifiers
NCT: NCT06626074 · 49RC23_0262 · 2024-A02056-41