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Exploratory Study of MRI Biomarkers of NASH

Exploratory Study of MRI Biomarkers of NASH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06626074
Acronym
IRM-NASH
Enrollment
110
Registered
2024-10-03
Start date
2025-09-05
Completion date
2027-09-06
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease NAFLD

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.

Interventions

DEVICEQuantitative MRI sequences

additional sequences during MRI

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV
Angers University
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosisthe outcome measurment is performed once during MRINASH is defined by histological criteria

Countries

France

Contacts

CONTACTAnita PAISANT, MD
anita.paisant@chu-angers.fr0241353637
CONTACTAnthéa LOIEZ
anthea.loiez@chu-angers.fr0241353637
PRINCIPAL_INVESTIGATORAnita PAISANT, MD

University Hospital, Angers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026