Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10+
SponsorOHSU Knight Cancer Institute

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

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

Celgene Corporation

Collaborator

Oregon Health and Science University

Collaborator