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.
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.
- Subjects receive Combidex and undergo a previously schedule neurosurgery.
- Subjects undergo surgery only and provide a sample of their tumor tissue to be used in
pathology studies of Combidex.
- Subjects with MS or stroke are invited to participate in receiving Combidex to evaluate
the effectiveness of enhancing the area of damage within the brain.
Subjects are deemed eligible for the study and undergo a baseline MRI within 28 days of
receiving Combidex. Subjects receiving Combidex are admitted for a half day into the Oregon
Clinical & Translational Research Institute(OCTRI). Combidex is infused I.V. over 30
minutes. Subjects are monitored for side effects and are discharged within about 5 hours
after the infusion, if no complications have been noted. Subjects return 24 hours after the
infusion for a post infusion MRI scan and return again to one of the neurology clinics for
one month follow-up. Subjects enrolled in group 2 undergo surgery 1-2 days after the
Combidex infusion and also undergo a 24 post infusion MRI and return for one month
follow-up. These subjects are also followed closely by the neurosurgical physician during
the course of follow-up. Subjects enrolled in group 3 only undergo surgery and agree to have
a piece of their tumor resection or biopsy donated for use in the study. Group 4 is the same
as group 1, except the patient population includes multiple sclerosis and stroke instead of
patients with brain tumors.
- 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
- 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