Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
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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
Drug: Technetium Tc 99m EC20
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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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
Pituitary Diseases Pituitary Neoplasms
Endocrine Gland Neoplasms Neoplasms by Site Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Technetium Tc 99m-ethylenedicysteine
Molecular Mechanisms of Pharmacological Action