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

July 27, 2015 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRI -

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)
MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Larry Kleinberg, MD, Sidney kimmel comprehensive cancer center at johns hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 8, 2007

First Submitted That Met QC Criteria

February 8, 2007

First Posted (Estimate)

February 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NABTT-2002 CDR0000274785
  • P30CA006973 (U.S. NIH Grant/Contract)
  • U01CA062475 (U.S. NIH Grant/Contract)
  • NABTT-2002
  • JHOC-NABTT-2002
  • ALLOS-RSR13CT-001i

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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