NCT01689714

Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Endocyte · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide an effective method to determine folate receptor-positive (FR+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.

Detailed description

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).

Conditions

• Ovarian Carcinoma
• Recurrent Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	Tc 99m EC20

Timeline

• Start date: 2003-08-01
• Completion: 2005-08-01
• First posted: 2012-09-21
• Last updated: 2023-06-22