Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases

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