MRI Exploration of Meningeal Inflammatory Disease

NCT04707170 | Completed

• 1 other identifier: JSY_2020_38
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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)

Conditions

MRI

Outcome Measures

Primary Outcomes (2)

• detection of meningeal contrast enhancement with the flair sequence

  1 DAY

• detection of meningeal contrast enhancement with the FABIR sequence

  1 day

Interventions

MRI with gadolinium injection DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• Express consent to participate in the study
• Affiliate or beneficiary of a social security scheme

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hhopital fondation adolphe de rothschild

Paris, 75019, France

Location

Study Officials

• julien savatovsky

  Hôpital fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: June 16, 2021
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)