<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03245606</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_9794_FibroMR</org_study_id>
    <nct_id>NCT03245606</nct_id>
  </id_info>
  <brief_title>Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non Alcoholic Fatty Liver Disease</brief_title>
  <acronym>FibroMR</acronym>
  <official_title>Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non-Alcoholic Fatty Liver Disease (NAFLD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective is to compare the accuracy of transient elastography taking into account&#xD;
      liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in&#xD;
      patient with NAFLD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No alcoholic fatty liver disease (NAFLD) is induced by an abnormal build up of fat in the&#xD;
      liver. It can induce liver damage, namely fibrosis, which leads to cirrhosis and an increased&#xD;
      risk of liver cancer. The diagnosis of liver fibrosis is thus critical to identify patients&#xD;
      at risk.&#xD;
&#xD;
      Liver biopsy is the gold standard for the diagnosis of liver fibrosis. However this invasive&#xD;
      test is expensive and has a significant morbidity.&#xD;
&#xD;
      To avoid this others non invasive test have been developed to assess steatosis and fibrosis&#xD;
      of the liver :&#xD;
&#xD;
        -  Magnetic Resonance Imaging can quantify liver steatosis accurately.&#xD;
&#xD;
        -  Transient elastography (Fibroscan®) is approved for the diagnosis of fibrosis in chronic&#xD;
           hepatitis C. However results in NAFLD were disappointing. Further, steatosis by&#xD;
           heightening liver elasticity is thought to be the cause of these poor results.&#xD;
&#xD;
        -  Several biological tests or score are also approved in chronic hepatitis C, but not in&#xD;
           NAFLD.&#xD;
&#xD;
      The hypothesis driving this study is that by accounting for liver steatosis through the mean&#xD;
      of MRI, we could more accurately interpret transient elastography value to accurately&#xD;
      diagnose the severity of liver fibrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2017</start_date>
  <completion_date type="Actual">July 7, 2020</completion_date>
  <primary_completion_date type="Actual">July 7, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD</measure>
    <time_frame>Day 1</time_frame>
    <description>Determination of the fibrosis stage by a double blind reading of liver biopsy by experienced pathologist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of accuracy of transient elastography taking into account liver steatosis determined by MRI, for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of accuracy of Acoustic Radiation Force Impulse for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">270</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Patients with Non Alcoholic Fatty Liver Disease</arm_group_label>
    <description>Patients (240) will undergo a medical examination in order to analyse their medical history and check inclusion and non-inclusion criterions.&#xD;
Then will be performed:&#xD;
a liver biopsy&#xD;
an abdominal MRI&#xD;
a transient elastography</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver biopsy</intervention_name>
    <description>Measurement of liver fibrosis</description>
    <arm_group_label>Patients with Non Alcoholic Fatty Liver Disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Abdominal MRI</intervention_name>
    <description>Measurement of liver fibrosis</description>
    <arm_group_label>Patients with Non Alcoholic Fatty Liver Disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transient elastography</intervention_name>
    <description>Measurement of liver fibrosis</description>
    <arm_group_label>Patients with Non Alcoholic Fatty Liver Disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with NAFLD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old&#xD;
&#xD;
          -  For which a liver biopsy is indicated for NAFLD according to current guidelines&#xD;
&#xD;
          -  Presenting with at least one of the metabolic syndrome criteria:&#xD;
&#xD;
               -  BMI &gt; 25 kg/m² and/or Waist circumference ≥ à 94cm for men / ≥ à 80cm for women&#xD;
&#xD;
               -  Fasting glucose &gt; or = to 5,6 mmol/L or diabetes / or lowering glucose treatment&#xD;
&#xD;
               -  Blood pressure ≥ 130/85 mmHg / or treatment&#xD;
&#xD;
               -  Triglycerides ≥ than 1,7 mmol/L&#xD;
&#xD;
               -  HDL-C ≤ than 1 mmol/L (men), ≤ 1,3 mmol/L (women) /or lipid lowering treatment&#xD;
&#xD;
          -  Affiliated to medical care insurance&#xD;
&#xD;
          -  Having signed informed consent for participating in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated other chronic liver disease : infectious, auto immune, genetic&#xD;
&#xD;
          -  Alcohol consumption higher than 21 standard unit per week for men, or 14 standard unit&#xD;
             for women;&#xD;
&#xD;
          -  Steatosis inducing treatment: steroids, amiodarone, methotrexate, tamoxifen&#xD;
&#xD;
          -  History of bariatric surgery&#xD;
&#xD;
          -  Contra indication to MRI (pace maker, metallic foreign body, claustrophobia)&#xD;
&#xD;
          -  Persons subject to major legal protection (safeguarding justice, guardianship,&#xD;
             trusteeship), persons deprived of liberty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Bretagne Sud</name>
      <address>
        <city>Lorient</city>
        <zip>56100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Saint Brieuc</name>
      <address>
        <city>Saint-Brieuc</city>
        <zip>22027</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Bretagne Atlantique</name>
      <address>
        <city>Vannes</city>
        <zip>56000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NAFLD</keyword>
  <keyword>steatosis</keyword>
  <keyword>fibrosis</keyword>
  <keyword>transient elastography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03245606
org study id: 35RC16_9794_FibroMR
nct id: NCT03245606
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective is to compare the accuracy of transient elastography taking into account
      liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in
      patient with NAFLD.
No alcoholic fatty liver disease (NAFLD) is induced by an abnormal build up of fat in the
      liver. It can induce liver damage, namely fibrosis, which leads to cirrhosis and an increased
      risk of liver cancer. The diagnosis of liver fibrosis is thus critical to identify patients
      at risk.

      Liver biopsy is the gold standard for the diagnosis of liver fibrosis. However this invasive
      test is expensive and has a significant morbidity.

      To avoid this others non invasive test have been developed to assess steatosis and fibrosis
      of the liver :

        -  Magnetic Resonance Imaging can quantify liver steatosis accurately.

        -  Transient elastography (Fibroscan®) is approved for the diagnosis of fibrosis in chronic
           hepatitis C. However results in NAFLD were disappointing. Further, steatosis by
           heightening liver elasticity is thought to be the cause of these poor results.

        -  Several biological tests or score are also approved in chronic hepatitis C, but not in
           NAFLD.

      The hypothesis driving this study is that by accounting for liver steatosis through the mean
      of MRI, we could more accurately interpret transient elastography value to accurately
      diagnose the severity of liver fibrosis.
observational model: Case-Only
time perspective: Prospective
measure: Comparison of the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD
time frame: Day 1
description: Determination of the fibrosis stage by a double blind reading of liver biopsy by experienced pathologist
measure: Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy
time frame: Day 1
measure: Assessment of accuracy of transient elastography taking into account liver steatosis determined by MRI, for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy
time frame: Day 1
measure: Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy
time frame: Day 1
measure: Assessment of accuracy of Acoustic Radiation Force Impulse for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy
time frame: Day 1
arm group label: Patients with Non Alcoholic Fatty Liver Disease
description: Patients (240) will undergo a medical examination in order to analyse their medical history and check inclusion and non-inclusion criterions.
Then will be performed:
a liver biopsy
an abdominal MRI
a transient elastography
intervention type: Procedure
intervention name: Liver biopsy
description: Measurement of liver fibrosis
arm group label: Patients with Non Alcoholic Fatty Liver Disease
intervention type: Device
intervention name: Abdominal MRI
description: Measurement of liver fibrosis
arm group label: Patients with Non Alcoholic Fatty Liver Disease
intervention type: Device
intervention name: Transient elastography
description: Measurement of liver fibrosis
arm group label: Patients with Non Alcoholic Fatty Liver Disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Liver Cirrhosis
mesh term: Fibrosis
sharing ipd: No