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

NCT04906941 | Completed

• 1 other identifier: JSY_2021_14
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

White Matter Disease

Outcome Measures

Primary Outcomes (1)

• mean of the delta observed between the QSM of the white matter before and after injection of gadolinium

  mean of the delta observed between the QSM of the white matter before and after injection of gadolinium

  1 DAY

Interventions

MRI DEVICE

SWI QSM 1.0iso 8 echos sequence performed before and after the injected MRI prescribed as part of the treatment. \* Sense 2 \* 2: 9min33s

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 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hhopital fondation adolphe de rothschild

Paris, Paris, 75019, France

Location

MeSH Terms

Conditions

Leukoencephalopathies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: January 21, 2022
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (1)