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Trial record 4 of 761 for:    "Visceral steatosis"

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

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ClinicalTrials.gov Identifier: NCT02575625
Recruitment Status : Unknown
Verified October 2015 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : October 14, 2015
Last Update Posted : October 16, 2015
Sponsor:
Collaborators:
Echosens
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Tours

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

Condition or disease Intervention/treatment Phase
Liver Steatosis Device: Fibroscan Biological: Blood test for biological assessment of liver function Device: MRI Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis
Study Start Date : April 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575625


Contacts
Contact: Frederic PATAT, MD, PhD 0247478209 patat@med.univ-tours.fr
Contact: Jean-Marc PERANAU, MD jm.perarnau@chu-tours.fr

Locations
France
University Hospital of Tours Recruiting
Tours, France, 37044
Contact: Frederic PATAT, MD, PhD    0247478209    patat@med.univ-tours.fr   
Contact: Jean-Marc PERARNAU, MD       jm.perarnau@chu-tours.fr   
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         
Sponsors and Collaborators
University Hospital, Tours
Echosens
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Frederic PATAT, MD, PhD CHRU Tours

Additional Information:
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02575625     History of Changes
Other Study ID Numbers: PHAO2011-FP/TRANSTEATOSE
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by University Hospital, Tours:
Liver steatosis
Steatohepatitis
Fibroscan

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics