MRI Using Ferumoxytol in Patients With Primary Brain Cancer or Brain Metastases From Lung or Breast Cancer

Inclusion Criteria:

• Adults must have either radiological or established histological diagnosis of the following general categories: high-grade glioma/CNS lymphoma or brain metastases from lung or breast cancer.
• Previously untreated patients must have a lesion on an imaging study
• Post treatment patients will have radiographic abnormalities that may or may not be recurrent tumor
• If a patient needs a biopsy or neurosurgical procedure for diagnostic and/or therapeutic purposes as necessary treatment for their disease, the scans will be assessed and the tissue assessed by histology and/or EM for iron particles. Only clinically indicated biopsy and/or surgery will be done and surgery is incidental to inclusion in the protocol.
• Patients must be 18 years or older for inclusion in this study.
• Patients may have had prior therapy for the primary brain tumor, including radiotherapy or chemotherapy.
• For those patients with metastatic disease previous therapy of the primary tumor is permitted.
• After entry into the study, patients are expected to be followed for approximately 4-6 weeks after the final infusion of ferumoxytol.
• All patients, or their legal guardians, must sign a written informed consent and 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-treatment radiological scans/studies for patients receiving ferumoxytol must be performed approximately 4-6 weeks prior to study entry.

Exclusion Criteria:

• Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness
• Patients 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). Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion.
• Patients who are pregnant or lactating or who suspect they might be pregnant.
• Adult patients who require monitored anesthesia for MRI scanning
• Patients with stage IV (GFR 15-29 mL/min/1.73 m2) or stage V (GFR <15 mL/min/1.73 m2) renal insufficiency.
• 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 Gd contrast material.
• Subjects with known hepatic insufficiency or cirrhosis.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol.
• Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions).