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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04465448
Other study ID # JSY_2020_25
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 17, 2020
Est. completion date June 16, 2022

Study information

Verified date December 2022
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date June 16, 2022
Est. primary completion date June 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

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