A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
This Phase II, limited institution, open-label, single-arm, baseline-controlled study is
designed to obtain data on the percentage of patients with recurrent or metastatic cancer
from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver,
colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased
uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the
FolateScan images, and verify product safety in patients with suspected recurrent or
metastatic disease from any solid tumor.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label
Nelson M Oyesiku, MD, PhD
Principal Investigator
Emory University
United States: Food and Drug Administration
EC20.8
NCT01684098
August 2003
August 2005
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