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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Procedure: Liver biopsy; Device: Abdominal MRI; Device: Transient elastography

Detailed Description

No alcoholic fatty liver disease (NAFLD) is induced by an abnormal build up of fat in the liver. It can induce liver damage, namely fibrosis, which leads to cirrhosis and an increased risk of liver cancer. The diagnosis of liver fibrosis is thus critical to identify patients at risk.

Liver biopsy is the gold standard for the diagnosis of liver fibrosis. However this invasive test is expensive and has a significant morbidity.

To avoid this others non invasive test have been developed to assess steatosis and fibrosis of the liver :

• Magnetic Resonance Imaging can quantify liver steatosis accurately.
• Transient elastography (Fibroscan®) is approved for the diagnosis of fibrosis in chronic hepatitis C. However results in NAFLD were disappointing. Further, steatosis by heightening liver elasticity is thought to be the cause of these poor results.
• Several biological tests or score are also approved in chronic hepatitis C, but not in NAFLD.

The hypothesis driving this study is that by accounting for liver steatosis through the mean of MRI, we could more accurately interpret transient elastography value to accurately diagnose the severity of liver fibrosis.

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers
  • Bordeaux, France, 33604
    • CHU de Bordeaux
  • La Roche-sur-Yon, France, 85925
    • CHD Vendée
  • Lorient, France, 56100
    • Groupe Hospitalier Bretagne Sud
  • Nantes, France, 44035
    • CHU de Nantes
  • Rennes, France, 35033
    • CHU de Rennes
  • Saint-Brieuc, France, 22027
    • CH de Saint Brieuc
  • Toulouse, France, 31059
    • CHU de Toulouse
  • Vannes, France, 56000
    • Centre Hospitalier Bretagne Atlantique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with NAFLD

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Measurement of liver fibrosis; Device: Abdominal MRI; Measurement of liver fibrosis; Device: Transient elastography; Measurement of liver fibrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2017
• Primary Completion (Actual): July 7, 2020
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: NAFLD; fibrosis; steatosis; transient elastography
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 35RC16_9794_FibroMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No