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NCT Number: NCT06626074

Exploratory Study of MRI Biomarkers of 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.

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Key information

Conditions

Non-alcoholic Fatty Liver Disease NAFLD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantitative MRI sequences

Device

additional sequences during MRI

Primary outcomes

Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis

Time frame: the outcome measurment is performed once during MRI

NASH is defined by histological criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Anita PAISANT, MD

CONTACT

[email protected]

0241353637 ext. +33

Anthéa LOIEZ

CONTACT

[email protected]

0241353637 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

Angers University

Registry information

Acronym: IRM-NASH

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Oct 3, 2024
Registry last updated: Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting