search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
magnetic resonance imaging (MRI)
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    MRI -

    Arm Description

    MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI Procedure/surgery magnetic resonance imaging (MRI)

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2007
    Last Updated
    July 27, 2015
    Sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00433472
    Brief Title
    MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial NABTT-9806
    Official Title
    Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    not enough interest
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain and Central Nervous System Tumors
    Keywords
    adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MRI -
    Arm Type
    Other
    Arm Description
    MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI Procedure/surgery magnetic resonance imaging (MRI)
    Intervention Type
    Device
    Intervention Name(s)
    magnetic resonance imaging (MRI)
    Other Intervention Name(s)
    MRI
    Intervention Description
    MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI
    Primary Outcome Measure Information:
    Title
    Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI
    Title
    Predicted oxygenation changes based on observed T2 MRI changes
    Title
    Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain
    Title
    Baseline oxygen extraction ratios in tumors
    Title
    New tumor- or non-tumor-related abnormalities on T2 and T2* MRI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Larry Kleinberg, MD
    Organizational Affiliation
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs