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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00433472
Study type Interventional
Source Sidney Kimmel Comprehensive Cancer Center
Contact
Status Withdrawn
Phase N/A

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