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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

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.

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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.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Primary Study Purpose

DIAGNOSTIC

Study Groups

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MRI -

MRI scan to be complete to look at RSR13 on measurement of T2 and T2\* on MRI

Procedure/surgery magnetic resonance imaging (MRI)

Group Type OTHER

magnetic resonance imaging (MRI)

Intervention Type DEVICE

MRI scan to be complete to look at RSR13 on measurement of T2 and T2\* on MRI

Interventions

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magnetic resonance imaging (MRI)

MRI scan to be complete to look at RSR13 on measurement of T2 and T2\* on MRI

Intervention Type DEVICE

Other Intervention Names

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MRI

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No