- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01689727
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
June 20, 2023 updated by: Endocyte
A Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
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.
Study Overview
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
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States
- Emory Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Technetium Tc 99m EC20
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nelson Oyesiku, MD, Emory Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
September 9, 2012
First Submitted That Met QC Criteria
September 17, 2012
First Posted (Estimated)
September 21, 2012
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Pituitary Neoplasms
- Pituitary Diseases
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Technetium Tc 99m-ethylenedicysteine
Other Study ID Numbers
- EC20.7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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