<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/NCT02992847</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0646</org_study_id>
    <nct_id>NCT02992847</nct_id>
  </id_info>
  <brief_title>Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)</brief_title>
  <official_title>Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guerbet</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several recent studies have shown an increase in the signal intensity of the unenhanced&#xD;
      T1-weighted magnetic resonance images in the brain of patients with normal renal functions&#xD;
      and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to&#xD;
      an accumulation of gadolinium based contrast agent. These studies were mainly conducted in&#xD;
      patients with primary or secondary brain tumor. Multiple sclerosis is a particular model&#xD;
      since it involves patients with a break of the blood-brain barrier, a long life expectancy,&#xD;
      and who received many injections of contrast enhancing agents. In this context, it appears&#xD;
      fundamental to know whether contrast agents accumulate in the brain for this disease. The&#xD;
      French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with&#xD;
      homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without&#xD;
      injection. The purpose of this study is to evaluate the accumulation of two commonly used&#xD;
      gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple&#xD;
      sclerosis, who received at least 5 injection of exclusively one of these contrast material.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit)</measure>
    <time_frame>12 months after last injection of contrast material for enhanced MR acquisition</time_frame>
    <description>Operator defined region of interest measure of signal intensity on unenhanced T1-weighted images after MR acquisition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EDSS (Expanded Disability Status Scale) score</measure>
    <time_frame>12 months after last injection of contrast material for enhanced MR acquisition</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Dotarem</arm_group_label>
    <description>At least 5 injection with Dotarem exclusively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multihance</arm_group_label>
    <description>At least 5 injection with Multihance exclusively</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unenhanced MRI</intervention_name>
    <arm_group_label>Dotarem</arm_group_label>
    <arm_group_label>Multihance</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from the French observatory of multiple sclerosis (www.ofsep.org/)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Multiple sclerosis&#xD;
&#xD;
          -  At least 5 MR imaging with the same Gadolinium based contrast agent (either Dotarem or&#xD;
             Multihance)&#xD;
&#xD;
          -  Have performed an unenhanced T1-weighted image before Gadolinium based contrast agent&#xD;
             injection according to the OFSEP protocol&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
          -  Never experienced other contrast agent then the one specified by the group to which&#xD;
             they belong (either Dotarem, or Multihance)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Francçois COTTON, MD</last_name>
    <phone>(0)4 78 86 21 37</phone>
    <phone_ext>+33</phone_ext>
    <email>francois.cotton@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stéphane KREMER, MD</last_name>
    <phone>(0)3 88 12 78 93</phone>
    <phone_ext>+33</phone_ext>
  </overall_contact_backup>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple sclerosis</keyword>
  <keyword>Gadolinium based contrast agent</keyword>
  <keyword>MRI</keyword>
  <keyword>Dentate nucleus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02992847
org study id: 69HCL16_0646
nct id: NCT02992847
lead sponsor: 
collaborator: 
has dmc: No
Several recent studies have shown an increase in the signal intensity of the unenhanced
      T1-weighted magnetic resonance images in the brain of patients with normal renal functions
      and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to
      an accumulation of gadolinium based contrast agent. These studies were mainly conducted in
      patients with primary or secondary brain tumor. Multiple sclerosis is a particular model
      since it involves patients with a break of the blood-brain barrier, a long life expectancy,
      and who received many injections of contrast enhancing agents. In this context, it appears
      fundamental to know whether contrast agents accumulate in the brain for this disease. The
      French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with
      homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without
      injection. The purpose of this study is to evaluate the accumulation of two commonly used
      gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple
      sclerosis, who received at least 5 injection of exclusively one of these contrast material.
observational model: Cohort
time perspective: Retrospective
measure: Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit)
time frame: 12 months after last injection of contrast material for enhanced MR acquisition
description: Operator defined region of interest measure of signal intensity on unenhanced T1-weighted images after MR acquisition
measure: EDSS (Expanded Disability Status Scale) score
time frame: 12 months after last injection of contrast material for enhanced MR acquisition
arm group label: Dotarem
description: At least 5 injection with Dotarem exclusively
arm group label: Multihance
description: At least 5 injection with Multihance exclusively
intervention type: Other
intervention name: Unenhanced MRI
arm group label: Dotarem
arm group label: Multihance
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francçois COTTON, MD
phone: (0)4 78 86 21 37
phone ext: +33
email: francois.cotton@chu-lyon.fr
last name: Stéphane KREMER, MD
phone: (0)3 88 12 78 93
phone ext: +33
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis