<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/NCT04448613</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00502-37</org_study_id>
    <nct_id>NCT04448613</nct_id>
  </id_info>
  <brief_title>Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema</brief_title>
  <acronym>PAGODE</acronym>
  <official_title>Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema</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 presence of optic disc swelling at the fundus is a non-specific clinical sign that can&#xD;
      occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. The diagnostic&#xD;
      range is vast, including inflammatory pathologies of the optic nerve, infiltrative or&#xD;
      compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to&#xD;
      mention the pseudo optic disc swelling found in drüsens.&#xD;
&#xD;
      MRI is increasingly being used as a first-line examination to obtain an etiologic diagnosis&#xD;
      in a patient with optic disc swelling. It allows a rapid diagnosis to be made in cases of&#xD;
      inflammatory pathology or compressive or infiltrative pathology. It can provide very&#xD;
      suggestive elements in the case of intracranial hypertension. It appears to be potentially&#xD;
      useful in diagnosing ischemic optic neuropathy or in directing towards an etiological&#xD;
      diagnosis of Giant Cell Arteritis.&#xD;
&#xD;
      The development of new high-resolution MRI sequences has made it possible to obtain extremely&#xD;
      fine resolutions of a few hundred microns in the plane. Apart from a few clinical cases and&#xD;
      small series, there is no precise evaluation of the interest of these new sequences in the&#xD;
      positive and etiological diagnosis of ophthalmological, neuro-ophthalmological and encephalic&#xD;
      pathologies responsible for the presence of optic disc swelling.&#xD;
&#xD;
      The objective of our study is therefore to evaluate the diagnostic contribution and the gain&#xD;
      in diagnostic confidence provided by these new sequences in the context of pathologies&#xD;
      manifesting as optic disc swelling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>FLAIR hypersignal size: larger diameters and area</measure>
    <time_frame>baseline</time_frame>
    <description>larger diameters and area of FLAIR hypersignal</description>
  </primary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Optic Disk</condition>
  <condition>Magnetic Resonance Imaging</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Patients with optic disc swelling diagnosed by a fundus and included in the study will have a brain MRI and visual pathways lasting 30 minutes.&#xD;
Two additional 10-minute sequences will be added to the standard protocol.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to the radiology service of the A. de Rothschild foundation and&#xD;
        presenting a papillary edema detected clinically at the back of the eye sent by the&#xD;
        emergency department for an MRI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years old&#xD;
&#xD;
          -  presenting a papillary edema detected clinically at the back of the eye&#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;
          -  MRI contraindication (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>amé YAVCHITZ</last_name>
    <phone>0148036431</phone>
    <email>ayavchitz@for.paris</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fondation Ophtalmologique Adolphe de Rothschild (FOR)</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amélie YAVCHITZ</last_name>
      <phone>0148036431</phone>
      <email>ayavchitz@for.paris</email>
    </contact>
    <investigator>
      <last_name>Augustin LECLER</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</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>Papilledema</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/NCT04448613
org study id: 2020-A00502-37
nct id: NCT04448613
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The presence of optic disc swelling at the fundus is a non-specific clinical sign that can
      occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. The diagnostic
      range is vast, including inflammatory pathologies of the optic nerve, infiltrative or
      compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to
      mention the pseudo optic disc swelling found in drüsens.

      MRI is increasingly being used as a first-line examination to obtain an etiologic diagnosis
      in a patient with optic disc swelling. It allows a rapid diagnosis to be made in cases of
      inflammatory pathology or compressive or infiltrative pathology. It can provide very
      suggestive elements in the case of intracranial hypertension. It appears to be potentially
      useful in diagnosing ischemic optic neuropathy or in directing towards an etiological
      diagnosis of Giant Cell Arteritis.

      The development of new high-resolution MRI sequences has made it possible to obtain extremely
      fine resolutions of a few hundred microns in the plane. Apart from a few clinical cases and
      small series, there is no precise evaluation of the interest of these new sequences in the
      positive and etiological diagnosis of ophthalmological, neuro-ophthalmological and encephalic
      pathologies responsible for the presence of optic disc swelling.

      The objective of our study is therefore to evaluate the diagnostic contribution and the gain
      in diagnostic confidence provided by these new sequences in the context of pathologies
      manifesting as optic disc swelling.
observational model: Case-Only
time perspective: Prospective
measure: FLAIR hypersignal size: larger diameters and area
time frame: baseline
description: larger diameters and area of FLAIR hypersignal
intervention type: Other
intervention name: MRI
description: Patients with optic disc swelling diagnosed by a fundus and included in the study will have a brain MRI and visual pathways lasting 30 minutes.
Two additional 10-minute sequences will be added to the standard protocol.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: amé YAVCHITZ
phone: 0148036431
email: ayavchitz@for.paris
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Papilledema