EIME: MRI Exploration of Meningeal Inflammatory Disease

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT04707170

Collaborator

(none)

300

Enrollment

Location

23.5

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
MRI	Device: MRI with gadolinium injection

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

MRI Exploration of Meningeal Inflammatory Disease

Actual Study Start Date :

Jun 16, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

detection of meningeal contrast enhancement with the flair sequence [1 DAY]
detection of meningeal contrast enhancement with the FABIR sequence [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hhopital fondation adolphe de rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

Principal Investigator: julien savatovsky, Hôpital fondation Adolphe de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04707170

Other Study ID Numbers:

JSY_2020_38

First Posted:

Jan 13, 2021

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 21, 2022