NCT03245606

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 270 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
PROCEDURE	Liver biopsy	Measurement of liver fibrosis
DEVICE	Abdominal MRI	Measurement of liver fibrosis
DEVICE	Transient elastography	Measurement of liver fibrosis

Timeline

• Start date: 2017-12-07
• Primary completion: 2020-07-07
• Completion: 2020-07-07
• First posted: 2017-08-10
• Last updated: 2020-07-14

Locations

9 sites across 1 country: France