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

Liver Steatosis Clinical Trial

— TRANSTEATOSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02575625
• Other study ID #: PHAO2011-FP/TRANSTEATOSE
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2015
• Last updated: October 14, 2015
• Start date: April 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University Hospital, Tours
• Contact: Frederic PATAT, MD, PhD
• Phone: 0247478209
• Email: patat[@]med.univ-tours.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy subjects - Steps 1 and 2

• Age between 18 and 65 years old (2 age groups for step 2 : 18-30 et 40-65 years-old)

• Written inform consent form signed

• Affiliated to medical insurance

• Alcohol consumption d'alcool < 20g/j for women, <30g/j for men

• Patients with liver steatosis - Step 2

• More than 18 years -old

• Written inform consent form signed

• Affiliated to medical insurance

• Patients with clean steatosis confirmed by histological results of a liver biopsy done the previous month

• Alcohol consumption d'alcool < 20g/j for women, <30g/j for men

Exclusion Criteria:

• Healthy subjects - Step 1

• Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks

• Pregnant women, lactating women, and women in age for procreation and without reliable contraception

• Presence of ascites

• Person under guardianship

• Healthy subjects - Step 2

• Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks

• Pregnant women, lactating women, and women in age for procreation and without reliable contraception

• Contraindication to MRI

• Presence of ascites

• Person under guardianship

• Healthy subjects - Steps 1 and 2

• Presence of liver tumor or ascites (diagnosed with MRI or ultrasonography)

• Abnormal liver function tests (increase of transaminases, gammaGT)

• Patients with liver steatosis - Step 2

• Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks

• Pregnant women, lactating women, and women in age for procreation and without reliable contraception

• Contraindication to MRI

• Presence of ascites

• liver tumor

• Serology anti VHC+ or Ag HBs+

• Infection by HIV

• Auto-immun hepatitis

• Genetic hemochromatosis, Wilson disease, lake of alpha-1-antitrypsin

• Fibrosis or liver cirrhosis at biopsy

• Person under guardianship

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

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Tours	Echosens, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viscosity in Pa.s	Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm	One day	No
Primary	Elasticity in kPa	Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm	One day	No
Secondary	Reproductibility quantification in arbitrary unit	The 5 estimated parameters (which describe visco-elasticity) will be used to quantify the medical device reproductibility	through study completion, an average of 2 years	No
Secondary	Age in years	The 5 estimated parameters (which describe visco-elasticity) and the age oh the healthy volunteers wil be used to study an age effect	through study completion, an average of 2 years	No
Secondary	Liver signal intensity changes in decibel	Adiposis charge will be assessed by measure of liver signal intensity decrease on T1 sequence in phase opposition compared to in phase signal, after correction by iron quantity	through study completion, an average of 2 years	No

External Links

•   Clinical Investigation Center - Technological Innovations
•   University Hospital of Tours