search
Back to results

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

Primary Purpose

Liver Steatosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fibroscan
Blood test for biological assessment of liver function
MRI
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Steatosis focused on measuring Liver steatosis, Steatohepatitis, Fibroscan

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of ToursRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fibroscan exam

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Reproductibility quantification in arbitrary unit
The 5 estimated parameters (which describe visco-elasticity) will be used to quantify the medical device reproductibility
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
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

Full Information

First Posted
September 30, 2015
Last Updated
October 14, 2015
Sponsor
University Hospital, Tours
Collaborators
Echosens, Institut National de la Santé Et de la Recherche Médicale, France
search

1. Study Identification

Unique Protocol Identification Number
NCT02575625
Brief Title
Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis
Acronym
TRANSTEATOSE
Official Title
Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
Collaborators
Echosens, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Steatosis
Keywords
Liver steatosis, Steatohepatitis, Fibroscan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibroscan exam
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Fibroscan
Intervention Description
Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography.
Intervention Type
Biological
Intervention Name(s)
Blood test for biological assessment of liver function
Intervention Description
Blood test for biological assessment of liver function
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
Liver MRI
Primary Outcome Measure Information:
Title
Viscosity in Pa.s
Description
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
Time Frame
One day
Title
Elasticity in kPa
Description
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
Time Frame
One day
Secondary Outcome Measure Information:
Title
Reproductibility quantification in arbitrary unit
Description
The 5 estimated parameters (which describe visco-elasticity) will be used to quantify the medical device reproductibility
Time Frame
through study completion, an average of 2 years
Title
Age in years
Description
The 5 estimated parameters (which describe visco-elasticity) and the age oh the healthy volunteers wil be used to study an age effect
Time Frame
through study completion, an average of 2 years
Title
Liver signal intensity changes in decibel
Description
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
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic PATAT, MD, PhD
Phone
0247478209
Email
patat@med.univ-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc PERANAU, MD
Email
jm.perarnau@chu-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic PATAT, MD, PhD
Organizational Affiliation
CHRU Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic PATAT, MD, PhD
Phone
0247478209
Email
patat@med.univ-tours.fr
First Name & Middle Initial & Last Name & Degree
Jean-Marc PERARNAU, MD
Email
jm.perarnau@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Frederic PATAT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Valerie GISSOT, MD
First Name & Middle Initial & Last Name & Degree
Jean-Marc PERARNAU, MD
First Name & Middle Initial & Last Name & Degree
Yannick BACQ, MD
First Name & Middle Initial & Last Name & Degree
Louis D'ALTEROCHE, MD

12. IPD Sharing Statement

Links:
URL
http://cic-it-tours.fr/
Description
Clinical Investigation Center - Technological Innovations
URL
http://www.chu-tours.fr/
Description
University Hospital of Tours

Learn more about this trial

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

We'll reach out to this number within 24 hrs