Adult Glioblastoma Clinical Trial
Official title:
Assessment of Hypoxia in Malignant Gliomas Using EF5
This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma. Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
PRIMARY OBJECTIVES:
I. Determine the presence and pattern of etanidazole derivative EF5 binding with tumor,
based on image and cellular analyses, in patients undergoing surgery or biopsy for newly
diagnosed supratentorial malignant gliomas.
II. Determine the level of EF5 binding within histologic subtypes of this tumor in these
patients.
Compare the relationship between hypoxia and clinical outcomes in patients with glioblastoma
multiforme (GBM) vs non-GBM.
III. Determine the spatial relationships between EF5 binding and tumor tissue biomarkers and
pathophysiologic processes (e.g., necrosis, proliferation, and apoptosis) in these patients.
IV. Determine the relationship between EF5 binding and Eppendorf needle electrode
measurements in these patients.
OUTLINE:
Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before
surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph
node samples are collected during surgery and stained for biological markers. Fluorescent
immunohistochemistry techniques are used to determine the presence, distribution, and levels
of EF5 binding.
Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year,
every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1½-2 years.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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