Completed

NCT Number: NCT04448054

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

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.

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Key information

Conditions

Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation A De Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: ICILOLA

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jun 25, 2020
Registry last updated: Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.