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

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ClinicalTrials.gov Identifier: NCT01689727
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : September 21, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pituitary Tumors Drug: Technetium Tc 99m EC20 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
Study Start Date : September 2002
Primary Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Technetium Tc 99m EC20 Drug: Technetium Tc 99m EC20

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689727

United States, Georgia
Emory Hospital
Atlanta, Georgia, United States
Sponsors and Collaborators
Principal Investigator: Nelson Oyesiku, MD Emory Hospital

Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT01689727     History of Changes
Other Study ID Numbers: EC20.7
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: September 21, 2012
Last Verified: September 2012

Keywords provided by Endocyte:
Pituitary Tumors

Additional relevant MeSH terms:
Pituitary Diseases
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Technetium Tc 99m-ethylenedicysteine
Molecular Mechanisms of Pharmacological Action