Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806
- Determine whether efaproxiral has a measurable effect on the brain as shown by T2
and/or T2* MRI in patients with recurrent or progressive malignant glioma enrolled on
- Determine predicted oxygenation changes based on observed T2 MRI changes in these
- Determine the effects of this drug on T2 and T2* MRI relaxation times of normal areas
of the brain in these patients.
- Determine baseline oxygen extraction ratios in tumors of patients treated with this
- Determine whether administration of this drug reveals any new tumor- or
non-tumor-related abnormalities on T2 and T2* MRI in these patients.
OUTLINE: This is an open-label, multicenter, pilot study.
Patients receive efaproxiral and carmustine on clinical trial NABTT-9806. During any one
course of treatment on that study, patients undergo MRI before oxygen administration
(baseline), before efaproxiral infusion, and then every 5 minutes until 1 hour after
efaproxiral and carmustine treatment. Data is evaluated for extent and intensity of T2/T2*
changes and oxygen concentration changes in both abnormal and normal brain.
PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study within 12-24
Primary Purpose: Diagnostic
Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI
Larry Kleinberg, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration