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

F

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Conditions

Multiple Sclerosis
White Matter Hyperintensity

Treatments

Other: MRI

Study type

Observational

Funder types

NETWORK

Identifiers

NCT04465448
JSY_2020_25

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

18 participants in 2 patient groups

healthy volunteers
Treatment:
Other: MRI
group case
Treatment:
Other: MRI

Trial contacts and locations

1

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Central trial contact

julien savatovsky; Amelie YAVCHITZ

Data sourced from clinicaltrials.gov

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