MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial NABTT-9806

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Device: magnetic resonance imaging (MRI)


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Recurrent or progressive glioma Currently enrolled on clinical trial NABTT-9806 PATIENT CHARACTERISTICS: No severe claustrophobia No cardiac pacemaker No MRI-incompatible metallic implant PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI -<br>MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI Procedure/surgery magnetic resonance imaging (MRI) | Device: magnetic resonance imaging (MRI)<br>* MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma