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

White Matter Disease Clinical Trial

— GADO-QSM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04906941
• Other study ID #: JSY_2021_14
• Status: Recruiting
• Start date: January 21, 2022
• Est. completion date: January 2024

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: amélie YAVCHITZ
• Phone: 0148036454
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukoencephalopathies
• White Matter Disease

Intervention

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

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	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