MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial 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.
Brain and Central Nervous System Tumors
Procedure: magnetic resonance imaging
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806|
- Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI [ Designated as safety issue: No ]
- Predicted oxygenation changes based on observed T2 MRI changes [ Designated as safety issue: No ]
- Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain [ Designated as safety issue: No ]
- Baseline oxygen extraction ratios in tumors [ Designated as safety issue: No ]
- New tumor- or non-tumor-related abnormalities on T2 and T2* MRI [ Designated as safety issue: No ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433472
|Study Chair:||Larry Kleinberg, MD||Sidney Kimmel Comprehensive Cancer Center|