<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/NCT04448054</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01216-33</org_study_id>
    <nct_id>NCT04448054</nct_id>
  </id_info>
  <brief_title>Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas</brief_title>
  <acronym>ICILOLA</acronym>
  <official_title>Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas</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>
      When patients arrive in the waiting room of the MRI department, patients will be given the&#xD;
      briefing note explaining the purpose of the study and how it is going. During the&#xD;
      consultation, the radiologist will check the inclusion and non-inclusion criteria, and will&#xD;
      take the time to answer all of the patient's questions about the study (or his family member&#xD;
      by telephone if the patient does not is not in a condition to give its consent).&#xD;
&#xD;
      The MRI examination will be performed on a 3T multi-parametric MRI. If the neurological&#xD;
      disorder presented by the patient does not require an injection as part of routine care, only&#xD;
      a high resolution 3D T2 sequence on the nasosinus cavities and the olfactory tract, called&#xD;
      bFFE-Xd for approximately 2 min.&#xD;
&#xD;
      If the neurological disorder presented by the patient requires an injection as part of&#xD;
      current care, the examination will be completed with the nasosinus and olfactory 3D bFFE-Xd&#xD;
      sequence, and the following additional sequences performed after post injection: a&#xD;
&#xD;
        -  3D FABIR 0.9 sequence covering the brain, dedicated to exploring the subarachnoid&#xD;
           spaces;&#xD;
&#xD;
        -  a 3D T1 TSE 0.7 sequence covering the brain looking for meningeal or encephalic contrast&#xD;
           enhancement,&#xD;
&#xD;
        -  FLAIR HR coronal sequence (high resolution) exploring the limbic system.&#xD;
&#xD;
        -  Optional: a 3D FLAIR &quot;labyrinth&quot; sequence in the event of hearing / balance problems; a&#xD;
           DCE infusion sequence (T1-WI) on the olfactory tract if olfactory disorder, which will&#xD;
           be the first sequence made at the time of injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">April 20, 2024</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</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>Percentage of patients included with at least one sign of neuromeningeal, neurosensory or neurovascular involvement on MRI imaging with the specific sequences used.</measure>
    <time_frame>baseline</time_frame>
    <description>percentage</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Case 1: Routine care protocol not requiring injection&#xD;
Realization of the non-injected MRI protocol adapted to the indication&#xD;
+ Addition of a 3D bFFE-Xd sequence (+ 2 min) The protocol will last the examination time usually provided by the current treatment according to the indication + 2 min of complementary sequence Case 2: Routine treatment protocol requiring an injection&#xD;
Realization of the injected MRI protocol adapted to the indication&#xD;
Before gadolinium injection:&#xD;
Addition of a 3D bFFE-Xd sequence (+ 2 min) before injection&#xD;
After gadolinium injection:&#xD;
Option 1: if olfaction disorder, addition of DCE perfusion sequence (T1-WI) which will be the 1st post injection sequence (+ 4 min 30)&#xD;
FABIR 0.9 3D sequence (+ 4 min)&#xD;
3D sequence T1 TSE 0.7 (+ 2 min 30)&#xD;
FLAIR HR coronal sequence (+ 3 min 30)&#xD;
Option 2: if hearing / balance disorder, adding 3D FLAIR &quot;labyrinth&quot; sequence (+ 6min) which will be the 1st post injection sequence</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient diagnosed with SARS-CoV-2, who should benefit from a brain MRI as part of care for&#xD;
        an acute / chronic neurological disorder.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient&gt; 18 years old Express consent to participate in the study Affiliate or beneficiary&#xD;
        of a social security scheme Patient with suspected SARS-CoV-2 infection in an epidemic&#xD;
        context, confirmed or not by PCR, or close contact with a case confirmed by PCR, typical&#xD;
        chest scanner (non-systematized frosted glass areas predominantly sub-pleural, and at a&#xD;
        later stage of alveolar condensation without excavations, nodules or masses) or positive&#xD;
        serology; Patient to benefit from a brain MRI for an indication within the scope of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient benefiting from a legal protection measure Pregnant or breastfeeding woman&#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>Amélie YAVCHITZ</last_name>
    <phone>0148036431</phone>
    <email>ayavchitz@for.paris</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fondation A De Rothschild</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>Guillaume POILLON</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 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04448054
org study id: 2020-A01216-33
nct id: NCT04448054
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
When patients arrive in the waiting room of the MRI department, patients will be given the
      briefing note explaining the purpose of the study and how it is going. During the
      consultation, the radiologist will check the inclusion and non-inclusion criteria, and will
      take the time to answer all of the patient's questions about the study (or his family member
      by telephone if the patient does not is not in a condition to give its consent).

      The MRI examination will be performed on a 3T multi-parametric MRI. If the neurological
      disorder presented by the patient does not require an injection as part of routine care, only
      a high resolution 3D T2 sequence on the nasosinus cavities and the olfactory tract, called
      bFFE-Xd for approximately 2 min.

      If the neurological disorder presented by the patient requires an injection as part of
      current care, the examination will be completed with the nasosinus and olfactory 3D bFFE-Xd
      sequence, and the following additional sequences performed after post injection: a

        -  3D FABIR 0.9 sequence covering the brain, dedicated to exploring the subarachnoid
           spaces;

        -  a 3D T1 TSE 0.7 sequence covering the brain looking for meningeal or encephalic contrast
           enhancement,

        -  FLAIR HR coronal sequence (high resolution) exploring the limbic system.

        -  Optional: a 3D FLAIR "labyrinth" sequence in the event of hearing / balance problems; a
           DCE infusion sequence (T1-WI) on the olfactory tract if olfactory disorder, which will
           be the first sequence made at the time of injection.
observational model: Case-Only
time perspective: Prospective
measure: Percentage of patients included with at least one sign of neuromeningeal, neurosensory or neurovascular involvement on MRI imaging with the specific sequences used.
time frame: baseline
description: percentage
intervention type: Other
intervention name: MRI
description: Case 1: Routine care protocol not requiring injection
Realization of the non-injected MRI protocol adapted to the indication
+ Addition of a 3D bFFE-Xd sequence (+ 2 min) The protocol will last the examination time usually provided by the current treatment according to the indication + 2 min of complementary sequence Case 2: Routine treatment protocol requiring an injection
Realization of the injected MRI protocol adapted to the indication
Before gadolinium injection:
Addition of a 3D bFFE-Xd sequence (+ 2 min) before injection
After gadolinium injection:
Option 1: if olfaction disorder, addition of DCE perfusion sequence (T1-WI) which will be the 1st post injection sequence (+ 4 min 30)
FABIR 0.9 3D sequence (+ 4 min)
3D sequence T1 TSE 0.7 (+ 2 min 30)
FLAIR HR coronal sequence (+ 3 min 30)
Option 2: if hearing / balance disorder, adding 3D FLAIR "labyrinth" sequence (+ 6min) which will be the 1st post injection sequence
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amélie YAVCHITZ
phone: 0148036431
email: ayavchitz@for.paris
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No