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

Liver Steatosis Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fatty Liver
• Liver Steatosis

• NCT number: NCT02575625
• Study type: Interventional
• Source: University Hospital, Tours
• Contact: Frederic PATAT, MD, PhD
• Phone: 0247478209
• Email: patat@med.univ-tours.fr
• Status: Recruiting
• Phase: N/A
• Start date: April 2013
• Completion date: October 2015