Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

PRIMARY OBJECTIVES:

I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol.

II. To test signal changes of T2*w multi-echo fast field echo (mFFE) scans before and after
contrast agent injection.

SECONDARY OBJECTIVES:

I. To test if ferumoxytol affects gadolinium enhanced MRI. II. To test if steady state
cerebral blood volume (CBV) maps are different at various magnetic field strengths.

III. To explore late ferumoxytol enhancement (optional MRI) hours to days after ferumoxytol
administration in various pathologies.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive gadolinium intravenously (IV) and then ferumoxytol IV and undergo
MRI over 60 minutes on day 1.

GROUP II: Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60
minutes on day 1.

After completion of study, patients are followed up at 2 and 6 weeks.

Inclusion Criteria:

- Subjects must have neurological findings (i.e. loss of consciousness, paresis, cranial
neuropathy, etc.), and/or radiological abnormalities in the brain (neoplastic or
non-neoplastic in nature)

- Subjects must be able to undergo MRI imaging without anesthesia

- All subjects, or their legal guardians, must sign a written informed consent and
Health Insurance Portability and Accountability Act (HIPAA) authorization in
accordance with institutional guidelines

- Subjects with a calculated glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2

- Sexually active women of child-bearing potential must agree to use adequate
contraception (hormonal or barrier method of birth control; surgical intervention i.e.
tubal ligation or vasectomy; post-menopausal < 6 months; or abstinence) for at least
two months after each cycle of the study; should a female become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately

Exclusion Criteria:

- Subjects with clinically significant signs of uncal herniation, such as acute
pupillary enlargement, rapidly developing motor changes (over hours), or rapidly
decreasing level of consciousness, are not eligible

- Subjects with known allergic or hypersensitivity reactions to parenteral iron,
parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide
preparations (Ferumoxytol Investigator?s Drug Brochure, 2009); subjects with
significant drug or other allergies or autoimmune diseases may be enrolled at the
investigator?s discretion

- Subjects who are pregnant or lactating or who suspect they might be pregnant

- 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
gadolinium containing contrast material

- Subjects with known iron overload (genetic hemochromatosis); in subjects with a family
history of hemochromatosis, hemochromatosis must be ruled out prior to study entry
with normal values of the following blood tests: transferrin saturation (TS) test and
serum ferritin (SF) test; all associated costs will be paid by the study

- Subject who have received ferumoxytol within 3 weeks of study entry

- Subjects with three or more drug allergies from separate drug classes