A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer
The study is designed to verify product safety, determine optimal imaging time, gather
efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses
for presence of folate receptors, in women with suspected ovarian or endometrial cancer.
Twelve subjects will be enrolled, with a minimum of five malignant cases, as determined by
histopathological evaluation.
Women with a suspected ovarian or endometrial mass who either 1) have fixed, paraffin
embedded tissue sample(s) available for immunohistochemical staining obtained from a
previous pathological evaluation or 2) are scheduled for a procedure to obtain tissue for
pathological evaluation that can be fixed and paraffin embedded for immunohistochemical
staining are eligible for this study. The ovarian mass may be either an initial finding,
e.g., found at a routine pelvic examination or to investigate symptoms, or the ovarian or
endometrial mass may be a finding suspicious of recurrent or residual tumor at follow-up
examination after surgical resection of confirmed ovarian or endometrial cancer. Patients
may not be pregnant or breastfeeding at enrollment.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
James W. Fletcher, MD
Principal Investigator
Indiana University
United States: Food and Drug Administration
EC20.2
NCT01686256
August 2001
Name | Location |
---|---|
Indiana University Medical Center | Indianapolis, Indiana 46202 |