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CompletedNCT04448054

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMRICase 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

Timeline

Start date
2020-05-20
Primary completion
2023-12-19
Completion
2023-12-19
First posted
2020-06-25
Last updated
2023-12-20

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04448054. Inclusion in this directory is not an endorsement.

Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas (NCT04448054) · Clinical Trials Directory