<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/NCT03269682</url>
  </required_header>
  <id_info>
    <org_study_id>FHN_2017_4</org_study_id>
    <nct_id>NCT03269682</nct_id>
  </id_info>
  <brief_title>Prevalence of Contrast Enhancement of the Oculomotor Nerve on 3D PD T1 MRI Sequence in Patients With Ophthalmoplegia</brief_title>
  <acronym>3D-III</acronym>
  <official_title>Prevalence of Contrast Enhancement of the Oculomotor Nerve on 3D PD T1 MRI Sequence in Patients With Ophthalmoplegia</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>
      Oculomotor nerve (third cranial nerve or &quot;III&quot;) palsy is a relatively frequent cause of&#xD;
      consultation in ophthalmology.&#xD;
&#xD;
      It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and&#xD;
      therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the&#xD;
      oculomotor tract is the first-line examination required. In our usual clinical practice, we&#xD;
      noticed in several patients unusual contrast enhancement within the oculomotor nerve on T1&#xD;
      sequence with gadolinium injection, observed in various locations along the nerve path&#xD;
      (cavernous and/ or intra-orbital segment).&#xD;
&#xD;
      This contrast enhancement, could confirm the nerve impairment This study aims to analyse the&#xD;
      efficiency of a new sequence 3D PD T1 which isotropic spatial resolution less than 1mm, not&#xD;
      yet described in the literature, to depict this enhancement.&#xD;
&#xD;
      In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this&#xD;
      MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate&#xD;
      differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis&#xD;
      (inflammatory or ischemic origin). This new sequence 3D PD T1 sequence focused on the III&#xD;
      could thus be systematically included in the usual MRI protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Actual">April 16, 2021</completion_date>
  <primary_completion_date type="Actual">April 16, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Contrast enhancement of the oculomotor nerve on 3D PD T1 MRI sequence (presence or absence, determined by a radiologist)</measure>
    <time_frame>Baseline</time_frame>
    <description>A double separate reading of the imaging will be carried out by an experienced radiologist and a junior radiologist on anonymized MRIs, with no access to clinical elements and interpretation of the other radiologist. In case of discrepancy between the radiologists, the final decision will be made by a third experienced radiologist under the same conditions (no access to clinical data, no access to the other evaluations).</description>
  </primary_outcome>
  <enrollment type="Actual">134</enrollment>
  <condition>Ophthalmoplegia</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D PD T1 MRI sequence</intervention_name>
    <description>After MRI has been performed (about 5 minutes of additional time compared to the usual sequences), a double reading of the MRI will be performed by two radiologists (1 experienced and 1 junior).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with ophtalmoplegia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or&#xD;
        progressive onset)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Absolute contraindication to MRI or injection of contrast agents.&#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>Fondation Ophtalmologique A. de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2021</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>Ophthalmoplegia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03269682
org study id: FHN_2017_4
nct id: NCT03269682
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Oculomotor nerve (third cranial nerve or "III") palsy is a relatively frequent cause of
      consultation in ophthalmology.

      It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and
      therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the
      oculomotor tract is the first-line examination required. In our usual clinical practice, we
      noticed in several patients unusual contrast enhancement within the oculomotor nerve on T1
      sequence with gadolinium injection, observed in various locations along the nerve path
      (cavernous and/ or intra-orbital segment).

      This contrast enhancement, could confirm the nerve impairment This study aims to analyse the
      efficiency of a new sequence 3D PD T1 which isotropic spatial resolution less than 1mm, not
      yet described in the literature, to depict this enhancement.

      In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this
      MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate
      differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis
      (inflammatory or ischemic origin). This new sequence 3D PD T1 sequence focused on the III
      could thus be systematically included in the usual MRI protocol.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Contrast enhancement of the oculomotor nerve on 3D PD T1 MRI sequence (presence or absence, determined by a radiologist)
time frame: Baseline
description: A double separate reading of the imaging will be carried out by an experienced radiologist and a junior radiologist on anonymized MRIs, with no access to clinical elements and interpretation of the other radiologist. In case of discrepancy between the radiologists, the final decision will be made by a third experienced radiologist under the same conditions (no access to clinical data, no access to the other evaluations).
intervention type: Device
intervention name: 3D PD T1 MRI sequence
description: After MRI has been performed (about 5 minutes of additional time compared to the usual sequences), a double reading of the MRI will be performed by two radiologists (1 experienced and 1 junior).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Ophthalmoplegia
sharing ipd: Undecided