Status:
TERMINATED
Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Brain Neoplasms
Eligibility:
All Genders
5-75 years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU. There are four groups of the study: * Subjects receive the combidex infusion only. * Subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00659334
Start Date
August 1 2000
End Date
March 1 2010
Last Update
December 21 2022
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239