About this trial
This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.
Eligibility criteria
Qualifiers
Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)
Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)
Neoplastic process elsewhere in the body that may affect the brain (i.e. possible metastasis, vascular compromise, treatment related changes, etc.)
Subjects must be able to undergo MRI imaging without anesthesia
Disqualifiers
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, 2009); 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 MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
Trial design
Treatments tested in this trial
- Ferumoxytol
- Gadolinium
- Magnetic Resonance Imaging
Treatment groups
Sponsors and collaborators
OHSU Knight Cancer Institute
Lead sponsor
Celgene Corporation
Collaborator
Oregon Health and Science University
Collaborator