Assessment of Hypoxia in Malignant Gliomas Using EF5
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
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Time to local recurrence
Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|