MRI Exploration of Meningeal Inflammatory Disease (EIME)

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)

Study Overview

• Status: Completed
• Conditions: MRI
• Intervention / Treatment: Device: MRI with gadolinium injection

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hhopital fondation adolphe de rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for imaging for whom an MRI examination with gadolinium injection has been prescribed and who meet the inclusion and non-inclusion criteria will be offered to participate in the study.

The patients included, hospitalized at the A. de Rothschild Foundation Hospital for at least 24 hours, may be included in the ancillary study to meet secondary objective number 5

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
detection of meningeal contrast enhancement with the flair sequence	1 DAY
detection of meningeal contrast enhancement with the FABIR sequence	1 day

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: julien savatovsky, Hôpital Fondation Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JSY_2020_38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No