Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating. It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent to the tumor location. Combidex may provide the ability to better see brain tumors and inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its ability to cross blood vessels into brain tumors, and because of its size and ability to get into the area next to brain tumors, could assist in the treatment of brain tumors with other drugs in the future.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• Brain tumor or CNS inflammatory lesion including stroke or MS

• 5 yrs old or older

• Able to undergo MRI without general anesthesia

• Agree to be followed for 1 month following infusion of Combidex

• Sign a written informed consent

• If female and of child-bearing potential, be postmenopausal, sterile, or be on birth control for 1 month prior to study

• Must have a pre-treatment MRI within 28 days before study

Exclusion Criteria:

• Clinically significant signs of uncal herniation

• Allergy to study drug, Combidex

• Hepatic insufficiency

• Stage IV or V renal insufficiency

• If female, pregnant or lactating

• Require anesthesia for MRI scanning

• Hemachromatosis