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The second imaging agent will be 99m
Tc-EC-annexin V. A clinical pilot study has been
completed and an IND application for a combination
Phase I/II clinical trial study has been submitted
to the FDA. The Phase I/II study, in addition to
safety, will assess tumor apoptosis (programmed cell
death) in patients with primary breast cancer and
detect and image treatment related apoptosis in
patients with primary breast cancer. Additional
indications will be studied in Phase III. It is
expected that by using 99mTc-EC-annexin V, the
radiation oncologist will be able to detect cell
death much sooner than current practice. Assessment
of tumor apoptosis will be useful to evaluate the
efficacy and mechanisms of therapy and disease
progression or regression.
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