Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping) (ERESI)

Many central nervous system pathologies have an inflammatory component, often associated with an accumulation of disability and more severe tissue damage.

In multiple sclerosis, the inflammatory process is in part characterized by the activation of microglia, an entity of the innate inflammatory system, as well as a breakdown of the blood-brain barrier. During inflammation, activated microglia may contain high levels of iron, characterizing its activated state.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis; White Matter Hyperintensity
• Intervention / Treatment: Other: MRI

Detailed Description

Several MRI imaging tools are known to be highly sensitive to tissue iron content and have become the method of choice to study brain iron, including in a pathological context such as multiple sclerosis.

Quantitative magnetic susceptibility mapping (QSM) is an emerging technique to access non-invasively the iron content in brain tissue. For some years this technique has been used in MS to characterize white matter lesions. Changes in the QSM value of the lesions have made it possible to describe lesions surrounded by an iron ring. Susceptibility MRI has also been proposed to highlight lesions according to their chronology.

The study of reproducibility is of particular importance when using QSM in longitudinal studies or in therapeutic trials. A better understanding of intra- and inter-subject variation in QSM measurements may also allow a more accurate estimate of the number of subjects needed to detect changes in studies. In order to be widely applied to various pathologies, it is therefore necessary to evaluate its reproducibility by estimating the intra- and inter-subject variability for future dissemination in clinical and pharmaceutical studies.

In this project, the invstigators propose to study the reproducibility of QSM acquisition.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hhopital fondation adolphe de rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Participation in the study will be offered to patients with MS (the primary indication for which QSM is studied) as well as to healthy volunteers among staff.

Description

Inclusion Criteria:

• Subject over 18 years old
• Consent to participate in the study
• Beneficiary of a social protection scheme
• Healthy volunteers: Consent to be informed if an unexpected anomaly is revealed by the imagery.
• Patients: With MS defined according to McDonald's revised criteria for spatial dissemination and temporal or clinical or radiological temporal dissemination and who should benefit from MRI in the imaging department

Exclusion Criteria:

• Absolute contraindication to 3T MRI
• Realization of an injected MRI (gadolinium) in the previous year
• Patient benefiting from a legal protection measure
• Pregnant or breastfeeding woman
• For healthy volunteers: History of neurological pathology or neurological pathology in progress

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers	Other: MRI; Those included will perform an MRI without injection to obtain the QSM then they will exit the machine and reinstall themselves there to perform the second measurement. They will then change the MRI machine to perform a third measurement
group case	Other: MRI; Those included will perform an MRI without injection to obtain the QSM then they will exit the machine and reinstall themselves there to perform the second measurement. They will then change the MRI machine to perform a third measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QSM signal difference at two acquisition times in white matter, on an individual scale	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: JSY_2020_25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No