DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors

PRIMARY OBJECTIVES:

I. To describe the vascular properties of pediatric brain tumors using ferumoxytol for
DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a
single MRI session.

II. To describe evolving imaging characteristics of tumor vasculature using DSC-MRI with
ferumoxytol and DCE-MRI with GBCA in pediatric brain tumor patients.

SECONDARY OBJECTIVES:

I. Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different
time points.

II. To describe number and size of tumors imaged. III. To assess histology and electron
microscopy (EM) on tissue samples. IV. To demonstrate differences in patients with prior
therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).

OUTLINE:

Patients receive ferumoxytol and gadolinium intravenously (IV) and then undergo DSC-MRI and
DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24
hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3
weeks apart over up to 2 years.

After completion of study treatment, patients are followed up at approximately 4-6 weeks.

Inclusion Criteria:

- Participant must have either radiological (presumptive) or established (proven)
histological diagnosis of a brain tumor or lesion

- Previously untreated participants must have a measureable lesion on an imaging study

- Participants undergoing active treatment, or who have completed treatment, will have
radiographic abnormalities that may or may not be recurrent tumor

- Those participants requiring surgical intervention for diagnostic and/or therapeutic
purposes as necessary for their disease are eligible; the tissue may be assessed by
histology and/or EM for iron particles; only clinically indicated biopsy and/or
surgery will be done

- Participants may have had prior therapy for the primary brain tumor, including
surgery, radiotherapy or chemotherapy

- After entry into the study, participants agree to be followed for up to 6 weeks after
the final infusion of ferumoxytol

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

- Baseline MRI studies for participants receiving ferumoxytol must be performed within
16 weeks of study entry

- Sexually active women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
treatment and for the duration of study treatment; should a female become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately

Exclusion Criteria:

- Participants 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

- Participants with known allergic or hypersensitivity reactions to parenteral iron,
parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide
preparations, are not eligible; participants with significant drug or other allergies
or autoimmune diseases may be enrolled at the Investigator's discretion

- Participants who are pregnant, lactating, or who suspect they might be pregnant are
not eligible

- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than
2.5 x upper limits of normal

- Glomerular filtration rate (GFR) < 50

- Participants 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
GBCA

- Participants with known hepatic insufficiency or cirrhosis

- Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral
therapy are ineligible

- Participants that have a known or suspected iron overload (genetic hemochromatosis or
history of multiple transfusions)