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

NCT ID: NCT01689727

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30

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.

Conditions

Pituitary Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Technetium Tc 99m EC20

Group Type: OTHER

Technetium Tc 99m EC20

Intervention Type: DRUG

Interventions

Technetium Tc 99m EC20

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endocyte

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelson Oyesiku, MD

Role: PRINCIPAL_INVESTIGATOR

Emory Hospital

Locations

Emory Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

EC20.7

Identifier Type: -

Identifier Source: org_study_id