MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to address safety and efficiency of a new iron particle contrast agent, ferumoxytol. This product may be more useful in viewing the vessels of the brain and areas in the brain on magnetic resonance imaging (MRI), or magnetic resonance angiography (MRA), than the standard substance, gadolinium, injected during MRI and MRA.

Other ways in which ferumoxytol may help include the following:

1. Ferumoxytol may provide the ability to better see inflammatory lesions on magnetic resonance imaging (MRI) scans

2. Ferumoxytol may be useful in its ability to cross blood vessels into inflammatory processes, and

3. Ferumoxytol, because of its size and ability to get into the area next to your inflammatory lesion and could assist in the treatment of inflammatory lesions association with cardiac surgery or CNS vascular surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• Subjects must have a clinical, radiological or established histological diagnosis of multiple sclerosis, stroke, or be requiring cardiac or CNS vascular surgery. Subjects with a CNS inflammatory lesion that is suspicious for neoplasm or radiation induced inflammation (vasculitis) will also be included (group 1a). McDonald's criteria will be used for the diagnosis of multiple sclerosis.

• Subjects must be 18 years or older

• Subjects will be followed for at least 1 month after the infusion of ferumoxytol.

• All subjects or their authorized representative must sign a written informed consent and give HIPAA authorization in accordance with institutional guidelines.

• Female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. These criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient.

• Karnofsky must be 30% or greater

Exclusion Criteria:

• Subjects with clinically significant signs of uncal herniation

• Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to Gd contrast material.

• Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations

• Subjects with known hepatic insufficiency or cirrhosis

• Subjects with known or suspected iron overload

• HIV-positive subjects on combination anti-retroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol

• Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.