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

NCT04465448 | Terminated

• 1 other identifier: JSY_2020_25
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Matter Hyperintensity; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• QSM signal difference at two acquisition times in white matter, on an individual scale

  baseline

Study Arms (2)

healthy volunteers

Other: MRI

group case

Other: MRI

Interventions

MRI OTHER

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; healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hhopital fondation adolphe de rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: December 17, 2020
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: December 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)