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

Phase 2

Completed

• Conditions: Pituitary Tumors
• Interventions: Drug: Technetium Tc 99m EC20

• Registration Number: NCT01689727
• Lead Sponsor: Endocyte

Brief 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.

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2004-09
• Status Verified: 2012-09
• Study First Submitted: 2012-09-09
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects must meet the following eligibility requirements to be enrolled in the study:

1. Subject must be 18 years of age or older.

2. Subject must have a pituitary tumor.

3. Subject must have good kidney function.

4. Subject must provide written informed consent prior to enrollment.

Exclusion Criteria

Subjects must be excluded if any of the following conditions are present:

1. Subject is pregnant or breastfeeding.
2. Subject is simultaneously participating in another investigational drug study.
3. Subject has completed the follow-up phase of any previous study loess than 30 days prior to enrollment in this study.
4. Subject is unable to tolerate conditions for radionuclide imaging.
5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Technetium Tc 99m EC20	Technetium Tc 99m EC20	-

Trial Locations

Locations (1)

Emory Hospital; 🇺🇸 Atlanta, Georgia, United States