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

October 14, 2015 updated by: University Hospital, Tours

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Tours, France, 37044
        • Recruiting
        • University Hospital of Tours
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frederic PATAT, MD, PhD
        • Sub-Investigator:
          • Valerie GISSOT, MD
        • Sub-Investigator:
          • Jean-Marc PERARNAU, MD
        • Sub-Investigator:
          • Yannick BACQ, MD
        • Sub-Investigator:
          • Louis D'ALTEROCHE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viscosity in Pa.s
Time Frame: One day
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
Elasticity in kPa
Time Frame: One day
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproductibility quantification in arbitrary unit
Time Frame: through study completion, an average of 2 years
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
Age in years
Time Frame: through study completion, an average of 2 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
Liver signal intensity changes in decibel
Time Frame: through study completion, an average of 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Echosens

Investigators

  • Principal Investigator: Frederic PATAT, MD, PhD, CHRU Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 12, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAO2011-FP/TRANSTEATOSE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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