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

Non-Alcoholic Fatty Liver Disease Clinical Trial

— FibroMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245606
• Other study ID #: 35RC16_9794_FibroMR
• Status: Completed
• Start date: December 7, 2017
• Est. completion date: July 7, 2020

Study information

• Verified date: July 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Procedure:
• Liver biopsy
Measurement of liver fibrosis

Device:
• Abdominal MRI
Measurement of liver fibrosis
• Transient elastography
Measurement of liver fibrosis

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Bordeaux	Bordeaux
France	CHD Vendée	La Roche-sur-Yon
France	Groupe Hospitalier Bretagne Sud	Lorient
France	CHU de Nantes	Nantes
France	CHU de Rennes	Rennes
France	CH de Saint Brieuc	Saint-Brieuc
France	CHU de Toulouse	Toulouse
France	Centre Hospitalier Bretagne Atlantique	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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