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

Pituitary Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689727
• Other study ID #: EC20.7
• Status: Completed
• Phase: Phase 2
• Start date: September 2002

Study information

• Verified date: September 2012
• Source: Endocyte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

3. 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.

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumors

Intervention

Drug:
• Technetium Tc 99m EC20

Locations

Country	Name	City	State
United States	Emory Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Endocyte

Country where clinical trial is conducted

United States,