<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/NCT04465448</url>
  </required_header>
  <id_info>
    <org_study_id>JSY_2020_25</org_study_id>
    <nct_id>NCT04465448</nct_id>
  </id_info>
  <brief_title>Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping)</brief_title>
  <acronym>ERESI</acronym>
  <official_title>Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      Many central nervous system pathologies have an inflammatory component, often associated with&#xD;
      an accumulation of disability and more severe tissue damage.&#xD;
&#xD;
      In multiple sclerosis, the inflammatory process is in part characterized by the activation of&#xD;
      microglia, an entity of the innate inflammatory system, as well as a breakdown of the&#xD;
      blood-brain barrier. During inflammation, activated microglia may contain high levels of&#xD;
      iron, characterizing its activated state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several MRI imaging tools are known to be highly sensitive to tissue iron content and have&#xD;
      become the method of choice to study brain iron, including in a pathological context such as&#xD;
      multiple sclerosis.&#xD;
&#xD;
      Quantitative magnetic susceptibility mapping (QSM) is an emerging technique to access&#xD;
      non-invasively the iron content in brain tissue. For some years this technique has been used&#xD;
      in MS to characterize white matter lesions. Changes in the QSM value of the lesions have made&#xD;
      it possible to describe lesions surrounded by an iron ring. Susceptibility MRI has also been&#xD;
      proposed to highlight lesions according to their chronology.&#xD;
&#xD;
      The study of reproducibility is of particular importance when using QSM in longitudinal&#xD;
      studies or in therapeutic trials. A better understanding of intra- and inter-subject&#xD;
      variation in QSM measurements may also allow a more accurate estimate of the number of&#xD;
      subjects needed to detect changes in studies. In order to be widely applied to various&#xD;
      pathologies, it is therefore necessary to evaluate its reproducibility by estimating the&#xD;
      intra- and inter-subject variability for future dissemination in clinical and pharmaceutical&#xD;
      studies.&#xD;
&#xD;
      In this project, the invstigators propose to study the reproducibility of QSM acquisition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 16, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>QSM signal difference at two acquisition times in white matter, on an individual scale</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">58</enrollment>
  <condition>White Matter Hyperintensity</condition>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>group case</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Those included will perform an MRI without injection to obtain the QSM then they will exit the machine and reinstall themselves there to perform the second measurement. They will then change the MRI machine to perform a third measurement</description>
    <arm_group_label>group case</arm_group_label>
    <arm_group_label>healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participation in the study will be offered to patients with MS (the primary indication for&#xD;
        which QSM is studied) as well as to healthy volunteers among staff.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject over 18 years old&#xD;
&#xD;
          -  Consent to participate in the study&#xD;
&#xD;
          -  Beneficiary of a social protection scheme&#xD;
&#xD;
          -  Healthy volunteers: Consent to be informed if an unexpected anomaly is revealed by the&#xD;
             imagery.&#xD;
&#xD;
          -  Patients: With MS defined according to McDonald's revised criteria for spatial&#xD;
             dissemination and temporal or clinical or radiological temporal dissemination and who&#xD;
             should benefit from MRI in the imaging department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absolute contraindication to 3T MRI&#xD;
&#xD;
          -  Realization of an injected MRI (gadolinium) in the previous year&#xD;
&#xD;
          -  Patient benefiting from a legal protection measure&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  For healthy volunteers: History of neurological pathology or neurological pathology in&#xD;
             progress&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Amelie YAVCHITZ</last_name>
    <phone>0148036454</phone>
    <email>ayavchitz@for.paris</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>julien savatovsky</last_name>
    <phone>0148036401</phone>
    <email>jsavatovsky@for.paris</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hhopital fondation adolphe de rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amelie ya</last_name>
      <phone>0148036454</phone>
      <email>ayavchitz@for.paris</email>
    </contact>
    <investigator>
      <last_name>julien savatovsky</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 11, 2022</last_update_submitted>
  <last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</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/NCT04465448
org study id: JSY_2020_25
nct id: NCT04465448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many central nervous system pathologies have an inflammatory component, often associated with
      an accumulation of disability and more severe tissue damage.

      In multiple sclerosis, the inflammatory process is in part characterized by the activation of
      microglia, an entity of the innate inflammatory system, as well as a breakdown of the
      blood-brain barrier. During inflammation, activated microglia may contain high levels of
      iron, characterizing its activated state.
Several MRI imaging tools are known to be highly sensitive to tissue iron content and have
      become the method of choice to study brain iron, including in a pathological context such as
      multiple sclerosis.

      Quantitative magnetic susceptibility mapping (QSM) is an emerging technique to access
      non-invasively the iron content in brain tissue. For some years this technique has been used
      in MS to characterize white matter lesions. Changes in the QSM value of the lesions have made
      it possible to describe lesions surrounded by an iron ring. Susceptibility MRI has also been
      proposed to highlight lesions according to their chronology.

      The study of reproducibility is of particular importance when using QSM in longitudinal
      studies or in therapeutic trials. A better understanding of intra- and inter-subject
      variation in QSM measurements may also allow a more accurate estimate of the number of
      subjects needed to detect changes in studies. In order to be widely applied to various
      pathologies, it is therefore necessary to evaluate its reproducibility by estimating the
      intra- and inter-subject variability for future dissemination in clinical and pharmaceutical
      studies.

      In this project, the invstigators propose to study the reproducibility of QSM acquisition.
observational model: Case-Control
time perspective: Prospective
measure: QSM signal difference at two acquisition times in white matter, on an individual scale
time frame: baseline
arm group label: healthy volunteers
arm group label: group case
intervention type: Other
intervention name: MRI
description: Those included will perform an MRI without injection to obtain the QSM then they will exit the machine and reinstall themselves there to perform the second measurement. They will then change the MRI machine to perform a third measurement
arm group label: group case
arm group label: healthy volunteers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amelie YAVCHITZ
phone: 0148036454
email: ayavchitz@for.paris
last name: julien savatovsky
phone: 0148036401
email: jsavatovsky@for.paris
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Multiple Sclerosis
sharing ipd: No