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

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.

Study Overview

• Status: Completed
• Conditions: Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2
• Intervention / Treatment: Other: MRI

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation A de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients included with at least one sign of neuromeningeal, neurosensory or neurovascular involvement on MRI imaging with the specific sequences used.	percentage	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A01216-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No