Brain and Central Nervous System Tumors Clinical Trial
Official title:
Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806
RATIONALE: Diagnostic procedures, such as MRI, may help doctors learn how efaproxiral works
in the brain and help plan the best treatment.
PURPOSE: This clinical trial is using MRI to evaluate the effect of efaproxiral on the brain
in patients with recurrent or progressive glioma receiving treatment on clinical trial
NABTT-9806.
OBJECTIVES:
- 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
NABTT-9806.
- Determine predicted oxygenation changes based on observed T2 MRI changes in these
patients.
- 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
drug.
- 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
months.
;
Primary Purpose: Diagnostic
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