MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial NABTT-9806
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Device: magnetic resonance imaging (MRI)
- Registration Number
- NCT00433472
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MRI - magnetic resonance imaging (MRI) MRI scan to be complete to look at RSR13 on measurement of T2 and T2\* on MRI Procedure/surgery magnetic resonance imaging (MRI)
- Primary Outcome Measures
Name Time Method Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI Predicted oxygenation changes based on observed T2 MRI changes Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain Baseline oxygen extraction ratios in tumors New tumor- or non-tumor-related abnormalities on T2 and T2* MRI
- Secondary Outcome Measures
Name Time Method