CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Gadoteridoldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03396822
NCT03396822N/ACompleted

Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis

University of Maryland, Baltimore·observational·Posted Jan 11, 2018·Updated Feb 28, 2024

In Brief

An observational study evaluating Gadoteridol for Multiple Sclerosis. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Multiple Sclerosis (MS) is an autoimmune disorder of the central nervous system. In MS, inflammation is known to attack areas of the brain, spinal cord, and optic nerves; resulting in disability. Current MRI technology provides an adequate view of the impact of MS on the "white matter" of the brain, which contains many of the connections between neurons. Quantification of lesions in the white matter due to MS are a standard part of clinical trials and clinical care in MS. However, it has long been known that MS not only can affect the white matter, but also the "gray matter," which contains the majority of the nerve cells in the brain and can cause inflammation in the meninges (the protective tissue that surrounds the brain and spinal cord). Autopsy studies have shown that the inflammation seen in the meninges is driven by a B-cells, a subset of white blood cells and that meningeal inflammation may be responsible for damage to the gray matter of the brain. Ocrelizumab is a new treatment for multiple sclerosis. This medication works by targeting and destroying circulating B-cells. It is thought that this may reduce the level of meningeal inflammation in patients with multiple sclerosis. By reducing meningeal inflammation, this medication may result in less damage to the gray matter and subsequently less disability in MS patients. In this study, the investigators will evaluate the use of a method on 7 tesla (7T) MRI to identify inflammation in the meninges as a potential predictor of response to ocrelizumab treatment for multiple sclerosis. Further, the investigators will evaluate if this MRI technique can be used to monitor the long-term effect of the medication on meningeal inflammation and the development of damage to the gray matter of the brain.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 11, 2018
Enrollment StartSep 24, 2018
Primary CompletionMay 25, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 8.5 years ago

Interventions

Gadoteridoldrug

gadolinium MRI contrast