Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00103038 : Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Subject must have either radiological or established histological diagnosis of the
following general categories:

- High-grade glioma/central nervous system (CNS) lymphoma or

- Brain metastases

- Previously untreated subjects must have a lesion on an imaging study

- Post treatment subjects will have radiographic abnormalities that may or may not be
recurrent tumor

- Subjects agree to be contacted 4-6 weeks after each study visit

- Subjects, or their legal guardian, 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; or 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

- Pre-imaging radiological scans/studies must be performed approximately 16 weeks prior
to study entry; but not less than 24 hours prior

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, 2012); 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 require monitored anesthesia for MRI scanning

- Subjects with renal insufficiency; glomerular filtration rate (GFR) < 50

- Subjects 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
gadolinium (Gd) contrast material

- Subjects with known hepatic insufficiency or cirrhosis

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

- Subjects with known or suspected iron overload (genetic hemochromatosis or history of
multiple transfusions)

- Subjects with three or more drug allergies from separate drug classes
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00103038      |      Link to official Clinicaltrials.gov listing
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