Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors

PRIMARY OBJECTIVES:

I. Testing the superiority of ferumoxytol-based steady state (SS)-cerebral blood volume (CBV)
maps over gadolinium-based contrast agent (GBCA)-based dynamic susceptibility weighted
(DSC)-CBV maps in visualizing pediatric brain tumor blood volume maps.

SECONDARY OBJECTIVES:

I. Correlation of relative cerebral blood volume (rCBV) with histology and genetic markers.

II. Assessment of therapeutic response. III. Assessment of late ferumoxytol enhancement at
various stages of disease.

OUTLINE:

Patients undergo magnetic resonance imaging (MRI) with GBCA per standard of care over 45-60
minutes and then receive ferumoxytol intravenously (IV) followed by MRI over 10 minutes on
day 1. Patients may optionally undergo MRI over 30 minutes without any contrast agent on day
2. Each study visit consisting of 2 days may repeat no more frequently than 4 weeks for up to
5 study visits at different stages of the disease as determined by the investigator.

After completion of study, patients are followed up at 2 and 6 weeks and then periodically
for 5 years.

Inclusion Criteria:

- Subjects with a presumed diagnosis of brain tumor (based on imaging) or a confirmed
brain tumor (based on pathology) before or after any oncologic treatment
(surgery/chemotherapy/radiation)

- 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 and men 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 3Tesla (3T) MRI, 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 4 weeks of study entry