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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-10-31

Brief Summary

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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

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Detailed Description

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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

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Liver Steatosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fibroscan exam

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 hepatic biopsy et whom the histological answer is clean steatosis (NAFLD).

Experimental procedures consist in:

* Fibroscan measure, preceded by tracking sonography.
* liver MRI (for substudy about MRI comparison, in step 2)
* a blood test for biological assessment of liver functions

Group Type EXPERIMENTAL

Fibroscan

Intervention Type DEVICE

Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography.

Blood test for biological assessment of liver function

Intervention Type BIOLOGICAL

Blood test for biological assessment of liver function

MRI

Intervention Type DEVICE

Liver MRI

Interventions

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Fibroscan

Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography.

Intervention Type DEVICE

Blood test for biological assessment of liver function

Intervention Type BIOLOGICAL

MRI

Liver MRI

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes