High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
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|ClinicalTrials.gov Identifier: NCT01973517|
Recruitment Status : Suspended (Logistical factors affecting recruitment)
First Posted : October 31, 2013
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Feraheme Drug: Gadolinium-based contrast|
Multiple sclerosis (MS) is a neurological disorder that affects young adults world-wide. Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). After IV injection, the particles are taken up by the monocyte-macrophage system and can also be used to track macrophage infiltration by magnetic resonance imaging (MRI) after systemic injection owing to the strong image contrast of the iron-loaded macrophages. Approximately 24 hours after their IV injection, free particles are cleared from the circulation and MR signal alterations are thought to arise from the capture of particles by circulating phagocytic cells that are attracted to inflammatory lesions.
In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis by taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Relapsing Remitting MS
Patients with relapsing remitting multiple sclerosis will be imaged under high-field (7T) MRI prior to and following administration of gadolinium-based contrast (0.1 mmol/kg IV). Afterwards, they will be administered Feraheme 5mg/kg IV via slow push, and they will return 24 hours or later after pharmaceutical administration for post-Feraheme MR imaging.
Patients with relapsing remitting multiple sclerosis will be administered Feraheme 5mg/kg IV via slow push once and imaged under high-field MRI at least 24 hours following administration, to allow for adequate clearance of intravascular pharmaceutical.
Other Name: Ferumoxytol
Drug: Gadolinium-based contrast
Patients with relapsing remitting multiple sclerosis will be administered gadolinium-based contrast at a dose of 0.1 mmol/kg IV once and imaged under high-field MRI immediately following administration.
Other Name: Gadolinium
- Number and location of enhancing brain lesions seen on 7 tesla MRI following Feraheme administration. [ Time Frame: Baseline ]Magnetic resonance images of the brains of subjects will be evaluated independently by two expert readers blinded to the demographic and clinical data. The location and number of multiple sclerosis lesions that enhance following Feraheme administration will be recorded. These lesions will be compared with non-enhancing lesions and lesions that enhance with gadolinium-based contrast.
- Number and location of enhancing brain lesions seen on 7 tesla MRI following gadolinium-based contrast administration. [ Time Frame: Baseline ]Magnetic resonance images of the brains of subjects will be evaluated independently by two expert readers blinded to the demographic and clinical data. The location and number of multiple sclerosis lesions that enhance following gadolinium-based contrast administration will be recorded. These lesions will be compared with non-enhancing lesions and lesions that enhance with Ferahame.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973517
|United States, California|
|Richard M. Lucas Center for Imaging (of Stanford University)|
|Stanford, California, United States, 94304|
|Stanford Hospitals and Clinics|
|Stanford, California, United States, 94305|
|Study Director:||Michael Zeineh, MD, PhD||Stanford University|
|Study Director:||Brian Rutt, PhD||Stanford University|