Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas
NCT ID: NCT04448054
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
100 participants
OBSERVATIONAL
2020-05-20
2023-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fondation A De Rothschild
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-A01216-33
Identifier Type: -
Identifier Source: org_study_id