Multi-disciplinary Study: MR, Histologic and EM Imaging of Intravenous Superparamagnetic Crystalline Particles (Combidex) to Brain, Intra-cerebral Tumors and in CNS Inflammation
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.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.
Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.
24 hours (some patients between 3 and 72 hours) after administration of Combidex
Edward A Neuwelt, MD
Oregon Health and Science University
United States: Food and Drug Administration
|Oregon Health & Science University||Portland, Oregon 97201|