NCT01689727

Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors

A Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Endocyte · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a ligand (EC20) designed to bind to the folate receptor. The study is designed as an open-label, baseline-controlled study.

Detailed description

This is a Phase 2 open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of subjects with pituitary tumors with increased uptake of FolateScan in tumors and correlate the immunohistochemical staining findings with the FolateScan images, in subjects with pituitary tumors.

Conditions

• Pituitary Tumors

Interventions

Type	Name	Description
DRUG	Technetium Tc 99m EC20

Timeline

• Start date: 2002-09-01
• Primary completion: 2004-09-01
• First posted: 2012-09-21
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States