Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
I. Correlate the level of EF5 binding with pre-treatment hemoglobin level and tumor grade
and stage in patients undergoing surgery or biopsy for cervical, endometrial, or ovarian
I. Correlate pre-treatment tumor hypoxia (as measured by EF5 binding) with time to
progression and time to recurrence in these patients.
II. Correlate EF5 binding with CD-31 expression (tumor vasculature), Ki-67 expression
(cellular proliferation), and erythropoietin signaling in these patients.
Patients receive EF5 IV over 1-2½ hours on day 1. Approximately 1-2 days later, patients
undergo tumor resection or biopsy. Patients' tumor tissue samples undergo
immunohistochemistry and flow cytometry to detect EF5 binding levels. Patients' blood is
drawn immediately before and 30-60 minutes and 1-2 days after receiving EF5 to measure
systemic EF5 binding levels.
Patients are followed at 30-45 days after administration of EF5 and then every 3-6 months
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Level of EF5 binding
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
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|