High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases

• Status: Withdrawn
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Ferrosoferric Oxide

Criteria

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?