NCT04448054: ICILOLA

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

Completed Last updated 20 December 2023

What this trial tests

trial testing MRI in Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2 in 100 participants. Completed in 19 December 2023.

Timeline

20 May 2020

Primary endpoint
19 December 2023

19 December 2023

Quick facts

Lead sponsor	Fondation Ophtalmologique Adolphe de Rothschild
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	20 May 2020
Primary completion	19 December 2023
Estimated completion	19 December 2023
Sites	1 location across France

Drugs / interventions tested

• MRI — full drug profile →

Conditions studied

• Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2 — all drugs for Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2 →

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild — full company profile →

Who can join

18 and older, any sex, with Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. SARS-Cov-2 Damage on the Nervous System and Mental Health.
   Boulkrane MS, Ilina V, Melchakov R, Arisov M, et al · · 2022 · cited 4× · PMID 34191699 · DOI 10.2174/1570159x19666210629151303