A Screening Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma
The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted
diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate
receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is
only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor
with high affinity and are brought into the cell via endocytosis. In contrast, folic acid
itself enters most normal cells via the reduced folate carrier, a pathway entirely
inaccessible to folate conjugates. Therefore, these folate conjugates are specific to
cancer cells.
This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled
study designed to verify product safety, gather data on the percentage of metastatic renal
cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate
sensitivity, specificity, accuracy, positive predictive value, and negative predictive value
of FolateScan compared to immunohistochemical staining (IHC).
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
United States: Food and Drug Administration
EC20.9
NCT01689766
November 2003
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Mayo Clinic | Rochester, Minnesota 55905 |