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


N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI

Safety Issue:

No

Principal Investigator

Larry Kleinberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000274785

NCT ID:

NCT00433472

Start Date:

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • adult anaplastic astrocytoma
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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