MRI Exploration of Meningeal Inflammatory Disease

Completed

• Conditions: MRI

• Registration Number: NCT04707170
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which two additional sequences of 6 minutes duration will be added.

The MRI of routine care includes at least the following sequences:

* 3D T1 TFE 1.0 isotropic (2 minutes)

* T2 TSE (2 minutes)

* 3D FLAIR pre-injection (opt) (3 minutes)

* 3D FLAIR post-injection (3 minutes)

As part of the research, the following sequences will be acquired:

* FABIR pre-injection (3 minutes)

* FABIR post-injection (3 minutes)

Patients hospitalized for a foreseeable duration of at least 24 hours will be offered participation in the longitudinal tab of the study, for which four non-injected MRI examinations will be performed. The examinations will be carried out remotely from the injected MRI (1h, 2h, 12h-15h, 24h-36h). These exams dedicated to research will include the following sequences for a maximum of 8 minutes:

* 3D T1 TFE 1.0 isotropic (2 minutes)

* 3D FLAIR (3 minutes)

* FABIR (3 minutes)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Study Start: 2021-06-16
• Primary Completion: 2023-06-16
• Study Completion: 2023-06-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• Patient over 18 years old
• To benefit as part of his treatment of an MRI with injection of gadolinium
• Express consent to participate in the study
• Affiliate or beneficiary of a social security scheme

For the ancillary study to meet secondary endpoint number 5:

• Patient over 18 years old
• To benefit as part of his treatment of an MRI with injection of gadolinium
• Hospitalized for an expected period of at least 48 hours after the time of inclusion
• Express consent to participate in the study
• Affiliate or beneficiary of a social security scheme

Exclusion Criteria

• Patient benefiting from a legal protection measure
• Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection of meningeal contrast enhancement with the FABIR sequence	1 day
detection of meningeal contrast enhancement with the flair sequence	1 DAY

Trial Locations

Locations (1)

Hhopital fondation adolphe de rothschild; 🇫🇷 Paris, France