Clinical Trial Details
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NCT03234309 : Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors
PhasePhase 2
AgesMin: 5 Years Max: 18 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

- 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
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