Clinical Trial Details
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NCT02359097 : Steady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Subjects must have a known or presumed radiological diagnosis of glioblastoma (GBM);
for presumed diagnosis of GBM, histological confirmation of GBM must be completed
within 12 weeks of enrollment; (subjects will be removed from study and non-evaluable
if no histologic diagnosis of GBM is confirmed)

- Subjects must be enrolled before starting chemoradiation, either pre -or post-surgery

- 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

- 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; 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 3 tesla (T) 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
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