MRI Exploration of Meningeal Inflammatory Disease

MRI Clinical Trial

— EIME  

Official title:

MRI Exploration of Meningeal Inflammatory Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707170
• Other study ID #: JSY_2020_38
• Status: Completed
• Start date: June 16, 2021
• Est. completion date: June 16, 2023

Study information

• Verified date: December 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• MRI

Intervention

Device:
• MRI with gadolinium injection
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.

Locations

Country	Name	City	State
France	Hhopital fondation adolphe de rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of meningeal contrast enhancement with the flair sequence		1 DAY
Primary	detection of meningeal contrast enhancement with the FABIR sequence		1 day