NCT02575625

Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition. This proof of concept validation is made up of two steps: * Step 1: feasibility study of the method on 10 healthy volunteers * Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom the histological answer is clean steatosis (NAFLD). Experimental procedures consist in: * Fibroscan measure, preceded by tracking ultrasonography. * liver MRI (for substudy about MRI comparison, in step 2) * a blood test for biological assessment of liver functions

Detailed description

Diagnosis of liver lipid overload (named liver steatosis), unrelated to alcohol consumption, still mainly based on histological exam of the liver. An histological continuity exists going from clean liver steatosis (Non Alcoholic Fatty Liver Disease, NAFLD) to steatohepatitis with signs of inflammation and tissue fibrosis (Non Alcoholic Steato-Hepatitis, NASH). It's now well-known that disease can evolve to cirrhosis and its complications. Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition. This proof of concept validation is made up of two steps: * Step 1: feasibility study of the method on 10 healthy volunteers * Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom the histological answer is clean steatosis (NAFLD). Measures on healthy volunteers enable to do an intra-operator reproductibility analysis, a study of an age effect and a search of potential mechanic aging of the liver. Experimental procedures consist in: * Fibroscan measure, preceded by tracking ultrasonography. * liver MRI (for substudy about MRI comparison, in step 2) * a blood test for biological assessment of liver functions The final aim of this study is to propose a device enable medical community to do in vivo hepatic rheology observation, highly correlated to liver lipid overload. After industrialization of this innovation, this diffusion could making easier patients follow-up.

Conditions

• Liver Steatosis

Interventions

Type	Name	Description
DEVICE	Fibroscan	Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography.
BIOLOGICAL	Blood test for biological assessment of liver function	Blood test for biological assessment of liver function
DEVICE	MRI	Liver MRI

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-10-14
• Last updated: 2015-10-16

Locations

1 site across 1 country: France