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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pituitary Tumors

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Principal Investigator

Nelson Oyesiku, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory Hospital

Authority:

United States: Food and Drug Administration

Study ID:

EC20.7

NCT ID:

NCT01689727

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Pituitary Tumors
  • Pituitary Tumors
  • Pituitary Neoplasms

Name

Location

Emory Hospital Atlanta, Georgia  30322