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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
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
Actual Primary Completion Date : September 2004

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 identifier (NCT number): NCT01689727

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United States, Georgia
Emory Hospital
Atlanta, Georgia, United States
Sponsors and Collaborators
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Principal Investigator: Nelson Oyesiku, MD Emory Hospital
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Responsible Party: Endocyte Identifier: NCT01689727    
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:
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Pituitary Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Technetium Tc 99m-ethylenedicysteine
Molecular Mechanisms of Pharmacological Action