Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Subject must provide written informed consent prior to enrollment.
Exclusion criteria
Subjects must be excluded if any of the following conditions are present:
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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