Overview

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.