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).
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Val J Lowe, MD
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
EC20.4
NCT01689714
August 2003
August 2005
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