Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non Alcoholic Fatty Liver Disease

NCT03245606 | Completed

• 1 other identifier: 35RC16_9794_FibroMR
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 9

Brief Summary

The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD; steatosis; fibrosis; transient elastography

Outcome Measures

Primary Outcomes (1)

• Comparison of the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD

  Determination of the fibrosis stage by a double blind reading of liver biopsy by experienced pathologist

  Day 1

Secondary Outcomes (4)

• Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy

  Day 1

• Assessment of accuracy of transient elastography taking into account liver steatosis determined by MRI, for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy

  Day 1

• Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy

  Day 1

• Assessment of accuracy of Acoustic Radiation Force Impulse for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy

  Day 1

Study Arms (1)

Patients with Non Alcoholic Fatty Liver Disease

Patients (240) will undergo a medical examination in order to analyse their medical history and check inclusion and non-inclusion criterions. Then will be performed: * a liver biopsy * an abdominal MRI * a transient elastography

Procedure: Liver biopsy; Device: Abdominal MRI; Device: Transient elastography

Interventions

Liver biopsy PROCEDURE

Measurement of liver fibrosis

Patients with Non Alcoholic Fatty Liver Disease

Abdominal MRI DEVICE

Measurement of liver fibrosis

Patients with Non Alcoholic Fatty Liver Disease

Transient elastography DEVICE

Measurement of liver fibrosis

Patients with Non Alcoholic Fatty Liver Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with NAFLD

You may qualify if:

• Patients older than 18 years old
• For which a liver biopsy is indicated for NAFLD according to current guidelines
• Presenting with at least one of the metabolic syndrome criteria:
• BMI \> 25 kg/m² and/or Waist circumference ≥ à 94cm for men / ≥ à 80cm for women
• Fasting glucose \> or = to 5,6 mmol/L or diabetes / or lowering glucose treatment
• Blood pressure ≥ 130/85 mmHg / or treatment
• Triglycerides ≥ than 1,7 mmol/L
• HDL-C ≤ than 1 mmol/L (men), ≤ 1,3 mmol/L (women) /or lipid lowering treatment
• Affiliated to medical care insurance
• Having signed informed consent for participating in the study

You may not qualify if:

• Associated other chronic liver disease : infectious, auto immune, genetic
• Alcohol consumption higher than 21 standard unit per week for men, or 14 standard unit for women;
• Steatosis inducing treatment: steroids, amiodarone, methotrexate, tamoxifen
• History of bariatric surgery
• Contra indication to MRI (pace maker, metallic foreign body, claustrophobia)
• Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (9)

CHU d'Angers

Angers, 49933, France

Location

CHU de Bordeaux

Bordeaux, 33604, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Groupe Hospitalier Bretagne Sud

Lorient, 56100, France

Location

CHU de Nantes

Nantes, 44035, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CH de Saint Brieuc

Saint-Brieuc, 22027, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56000, France

Location

Related Publications (1)

• Masrour O, Ehrhard F, Guillaume M, Boursier J, Gournay J, Aziz K, Schnee M, Garlantezec R, de Ledinghen V, Morcet J, Laine F, Allaume P, Turlin B, Gandon Y, Bardou-Jacquet E. Diagnostic accuracy of transient elastography in MASLD is independent of MRI-PDFF steatosis in a multicenter study. JHEP Rep. 2025 Sep 11;7(12):101589. doi: 10.1016/j.jhepr.2025.101589. eCollection 2025 Dec.

  PMID: 41334457 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: December 7, 2017
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)