Viewing Study NCT04465448



Ignite Creation Date: 2024-05-06 @ 2:54 PM
Last Modification Date: 2024-10-26 @ 1:39 PM
Study NCT ID: NCT04465448
Status: TERMINATED
Last Update Posted: 2023-12-18
First Post: 2020-07-07

Brief Title: Evaluation of the Reproducibility of the Measurement of the QSM Signal Quantitative Susceptibility Mapping
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Organization: Fondation Ophtalmologique Adolphe de Rothschild

Study Overview

Official Title: Evaluation of the Reproducibility of the Measurement of the QSM Signal Quantitative Susceptibility Mapping
Status: TERMINATED
Status Verified Date: 2022-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: MRI issue
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ERESI
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None