Exploratory Study of MRI Biomarkers of NASH (IRM-NASH)

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.

Study Overview

• Status: Recruiting
• Conditions: Non-alcoholic Fatty Liver Disease NAFLD
• Intervention / Treatment: Device: Quantitative MRI sequences

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthéa LOIEZ; Phone Number: +33 0241353637; Email: anthea.loiez@chu-angers.fr
• Study Contact Backup: Name: Anita PAISANT, MD; Phone Number: +33 0241353637; Email: anita.paisant@chu-angers.fr

Study Locations

• France
  • France
    • Angers, France, France, 49000
      • Recruiting
      • University Hospital, Angers
      • Contact: Anita PAISANT; Phone Number: +33 0241353637; Email: anita.paisant@chu-angers.fr
      • Contact: Marie BOST; Phone Number: +33 0241353637; Email: MaBost@chu-angers.fr
      • Principal Investigator: Anita PAISANT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open label	Device: Quantitative MRI sequences; additional sequences during MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: University Angers
• Investigators: Principal Investigator: Anita PAISANT, MD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2025
• Primary Completion (Estimated): September 5, 2027
• Study Completion (Estimated): September 6, 2027

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 49RC23_0262; 2024-A02056-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
• IPD Sharing Access Criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No