Back to resultsSafety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
Primary Purpose
Pituitary Tumors
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Technetium Tc 99m EC20
Sponsored by
About this trial
This is an interventional other trial for Pituitary Tumors focused on measuring Pituitary Tumors
Eligibility Criteria
Inclusion Criteria:
Subjects must meet the following eligibility requirements to be enrolled in the study:
- Subject must be 18 years of age or older.
- Subject must have a pituitary tumor.
- 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:
- Subject is pregnant or breastfeeding.
- Subject is simultaneously participating in another investigational drug study.
- Subject has completed the follow-up phase of any previous study loess than 30 days prior to enrollment in this study.
- Subject is unable to tolerate conditions for radionuclide imaging.
- Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Sites / Locations
- Emory Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Technetium Tc 99m EC20
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01689727
Brief Title
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
Official Title
A Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endocyte
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Tumors
Keywords
Pituitary Tumors
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Technetium Tc 99m EC20
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Technetium Tc 99m EC20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must meet the following eligibility requirements to be enrolled in the study:
Subject must be 18 years of age or older.
Subject must have a pituitary tumor.
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:
Subject is pregnant or breastfeeding.
Subject is simultaneously participating in another investigational drug study.
Subject has completed the follow-up phase of any previous study loess than 30 days prior to enrollment in this study.
Subject is unable to tolerate conditions for radionuclide imaging.
Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Oyesiku, MD
Organizational Affiliation
Emory Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Hospital
City
Atlanta
State/Province
Georgia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
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