Clinical Trial Details
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NCT00978562 : DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors
AgesMin: 5 Years Max: 18 Years
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

- 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)
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