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Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas (ICILOLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448054
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

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.

Condition or disease Intervention/treatment
Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2 Other: MRI

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : November 20, 2021
Estimated Study Completion Date : November 20, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: MRI

    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


Primary Outcome Measures :
  1. 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 ]
    percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient diagnosed with SARS-CoV-2, who should benefit from a brain MRI as part of care for an acute / chronic neurological disorder.
Criteria

Inclusion Criteria:

Patient> 18 years old Express consent to participate in the study Affiliate or beneficiary of a social security scheme Patient with suspected SARS-CoV-2 infection in an epidemic context, confirmed or not by PCR, or close contact with a case confirmed by PCR, typical chest scanner (non-systematized frosted glass areas predominantly sub-pleural, and at a later stage of alveolar condensation without excavations, nodules or masses) or positive serology; Patient to benefit from a brain MRI for an indication within the scope of care

Exclusion Criteria:

Patient benefiting from a legal protection measure Pregnant or breastfeeding woman


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448054


Contacts
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Contact: Amélie YAVCHITZ 0148036431 ayavchitz@for.paris

Locations
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France
Fondation A De Rothschild Recruiting
Paris, France, 75019
Contact: Amélie YAVCHITZ    0148036431    ayavchitz@for.paris   
Principal Investigator: Guillaume POILLON         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04448054    
Other Study ID Numbers: 2020-A01216-33
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No