A MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FOLATESCAN (TECHNETIUM Tc 99m EC20) IN PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA
This phase 2, two-center, open-label, single-treatment group, within-patient-controlled
study was conducted to:
- Expand the safety database and gather data on the percentage of patients with known or
suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased
uptake of FolateScan in tumors (primary objective).
- Calculate the sensitivity, specificity, accuracy, positive predictive value, and
negative predictive value of FolateScan compared with immunohistochemical (IHC)
staining (secondary objective).
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Val J Lowe, MD
United States: Food and Drug Administration