Skip to main content
OpenTrials
Completed

NCT Number: NCT03245606

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Liver biopsy

Procedure

Measurement of liver fibrosis

Abdominal MRI

Device

Measurement of liver fibrosis

Transient elastography

Device

Measurement of liver fibrosis

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

    Time frame: Day 1

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

Secondary outcomes

  1. 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

    Time frame: Day 1

  2. 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

    Time frame: Day 1

  3. 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

    Time frame: Day 1

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

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: FibroMR

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2017
Registry last updated
Jul 14, 2020

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.

Published trials that share one or more normalized conditions with this study.