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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00433472
• Other study ID #: NABTT-2002 CDR0000274785
• Secondary ID: U01CA062475P30CA
• Status: Withdrawn
• Phase: N/A
• First received: February 8, 2007
• Last updated: July 27, 2015

Study information

• Verified date: July 2015
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Device:
• magnetic resonance imaging (MRI)
MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI			No
Primary	Predicted oxygenation changes based on observed T2 MRI changes			No
Primary	Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain			No
Primary	Baseline oxygen extraction ratios in tumors			No
Primary	New tumor- or non-tumor-related abnormalities on T2 and T2* MRI			No