<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/NCT04451265</url>
  </required_header>
  <id_info>
    <org_study_id>GPN_2020_6</org_study_id>
    <nct_id>NCT04451265</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy</brief_title>
  <acronym>DACODAC</acronym>
  <official_title>Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy</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>
      The patient presents to the ophthalmological emergencies and / or to the internal medicine&#xD;
      department. NOIA clinical discovery Patient referred in radiology for brain and visual MRI.&#xD;
      The two sequences added by the research (8 minutes) will be added to that of the treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 2022</start_date>
  <completion_date type="Anticipated">March 2028</completion_date>
  <primary_completion_date type="Anticipated">September 2027</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>Study the sensitivity of the High resolution Diffusion sequence in the detection of NOIA, evaluated by a DWI hypersignal and an ADC hyposignal of the optic nerve</measure>
    <time_frame>basline</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Neuro-Ophthalmology</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Diffusion sequence (8 minutes long) added to the initial MRI</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspected NOIA, discussed after clinical examination by a specialist&#xD;
        ophthalmologist&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years old&#xD;
&#xD;
          -  Patient with suspected NOIA, evoked after clinical examination by a specialized&#xD;
             ophthalmologist&#xD;
&#xD;
          -  For which a brain and visual MRI is planned&#xD;
&#xD;
          -  Express consent to participate in the study&#xD;
&#xD;
          -  Affiliate or beneficiary of a Social Security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to MRI (electrical device, metallic foreign body, claustrophobia)&#xD;
&#xD;
          -  Patient benefiting from a legal protection measure&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Amelie YAVCHITZ</last_name>
    <phone>0148036431</phone>
    <email>ayavchitz@for.paris</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>sidney krystal</last_name>
    <phone>0148036401</phone>
    <email>skrystal@for.paris</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de LILLE</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Olivier OUTTERYCK</last_name>
      <phone>0320225050</phone>
      <email>Olivier.OUTTERYCK@CHRU-LILLE.FR</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondation A De Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Amelie YAVCHITZ</last_name>
      <phone>0148036431</phone>
      <email>ayavchitz@for.paris</email>
    </contact>
    <investigator>
      <last_name>Candice Sabben, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre Seners, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76100</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Emmanuel GERARDIN</last_name>
      <phone>02 32 08 22 50</phone>
      <email>Emmanuel.Gerardin@chu-rouen.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 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 12, 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>Optic Nerve Diseases</mesh_term>
    <mesh_term>Optic Neuropathy, Ischemic</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/NCT04451265
org study id: GPN_2020_6
nct id: NCT04451265
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The patient presents to the ophthalmological emergencies and / or to the internal medicine
      department. NOIA clinical discovery Patient referred in radiology for brain and visual MRI.
      The two sequences added by the research (8 minutes) will be added to that of the treatment.
observational model: Case-Only
time perspective: Prospective
measure: Study the sensitivity of the High resolution Diffusion sequence in the detection of NOIA, evaluated by a DWI hypersignal and an ADC hyposignal of the optic nerve
time frame: basline
intervention type: Other
intervention name: MRI
description: Diffusion sequence (8 minutes long) added to the initial MRI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Amelie YAVCHITZ
phone: 0148036431
email: ayavchitz@for.paris
last name: sidney krystal
phone: 0148036401
email: skrystal@for.paris
facility: 
contact: 
facility: 
contact: 
investigator: 
investigator: 
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Optic Nerve Diseases
mesh term: Optic Neuropathy, Ischemic
sharing ipd: No