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High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
Not Recruiting
Trial ID: NCT01973517
Purpose
Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide
nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). 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 taking advantage of ultra
high field strength (7T) MRI to further increase the effectiveness of the contrast agent
Feraheme at revealing inflammatory activity.
Official Title
7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Patients will be included if they are at least 18 years old and meet the revised
diagnostic criteria for multiple sclerosis, relapsing remitting type.
- Patients will be included based on MR evidence of disease activity after Gadolinium
(enhanced lesion) on a previous screening MR in the previous 3 weeks days before
Feraheme administration.
Exclusion Criteria:
- Children (age < 18)
- Those who lack decision-making capability
- Contraindication to MRI such as pacemaker, other MR-incompatible metal implants or
claustrophobia
- Known allergy to dextran or drugs containing iron salts or any previous history of
severe allergic reactions
- Evidence of iron overload such as hemochromatosis or other hematologic disorders that
imply iron level superior to the normal level.
- Pregnancy or breast feeding.
- History of renal disease or estimated glomerular filtration rate (eGFR) using the
Modification of Diet in Renal Disease (MDRD) <40ml/min/1.73m?
Intervention(s):
drug: Feraheme
drug: Gadolinium-based contrast
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305