Assessment of the Impact of Gadolinium Injection on the Measurement of the QSM Signal

Recruiting

• Conditions: White Matter Disease

• Registration Number: NCT04906941
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Detailed Description

Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2022-01-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients over 18 years old
• with an inflammatory CNS pathology
• to benefit as part of care from an MRI with injection of gadolinium
• consent to participate in the study
• beneficiary of a social protection scheme

Exclusion Criteria

• pregnant or breastfeeding woman
• patient benefiting from a legal protection measure
• Patient having performed more than 3 MRI exams with gadolinium injection during his life

Secondary exclusion criteria :

• motion artifact not allowing image interpretation
• patient who has not completed one of the following sequences: T1 anatomical, FLAIR, or QSM pre-gadolinium injection.

Secondarily excluded patients will be replaced up to a maximum of 25 patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean of the delta observed between the QSM of the white matter before and after injection of gadolinium	1 DAY	mean of the delta observed between the QSM of the white matter before and after injection of gadolinium

Trial Locations

Locations (1)

Hhopital fondation adolphe de rothschild; 🇫🇷 Paris, France