Exploratory Study of MRI Biomarkers of NASH
IRM-NASH
2 other identifiers
interventional
60
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedStudy Start
First participant enrolled
September 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 6, 2027
September 30, 2025
September 1, 2025
2 years
October 1, 2024
September 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis
NASH is defined by histological criteria
the outcome measurment is performed once during MRI
Study Arms (1)
Open label
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Angerslead
- University Angerscollaborator
Study Sites (1)
University Hospital, Angers
Angers, France, 49000, France
Study Officials
- PRINCIPAL INVESTIGATOR
Anita PAISANT, MD
University Hospital, Angers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2024
First Posted
October 3, 2024
Study Start
September 5, 2025
Primary Completion (Estimated)
September 5, 2027
Study Completion (Estimated)
September 6, 2027
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.