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CompletedNCT04906941GADO-QSMUpdated Jan 5, 2026

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

An observational study in White Matter Disease, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
73
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • White Matter Disease

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03

In context

Leukoencephalopathies

39 studies on the registry are indexed under Leukoencephalopathies; 16 are open to participants now.

This study's enrollment of 73 is below the median of 100 across 28 observational studies indexed under Leukoencephalopathies.

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Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
73 participants (actual)
Patient registry
No

Interventions

  • DeviceMRI

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

06

What researchers measure

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

    Time frame: 1 DAY

07

Study locations

1 site
  • Hhopital fondation adolphe de rothschild
    Paris, Paris 75019, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04906941
Responsible party
Sponsor
First posted
May 28, 2021
Start date
Jan 21, 2022
Primary completion
Jul 19, 2023
Completion
Jul 19, 2023
Last update
Jan 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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