Early Prediction of Pathology Response of Chemoradiotherapy With Fluoro-L-Thymidine (FLT) Positron Emission Tomography (PET)
The goal of this study is to obtain preliminary data and initial estimates of the FLT
ability(FluoroLThymidine)-PET (Positron Emission Tomography) to identify pathCR (pathologic
complete response) patients who have esophageal carinoma and undergo Chemo-RT prior to
surgery. Despite improvements in surgical management, long-term survival rates in patients
with esophageal cancer have not changed dramatically. Achievement in pathCR after
pre-operative CRT (chemoradiotherapy) is associated with improved patient outcomes; however,
there is no effective method to predict pathological response before surgery. Thus, a
patient with pathCR, for whom esophagectomy may be unnecessary, still undergoes surgery and
faces the prohibitive side effects of this surgical procedure. Additionally, CRT is
associated with considerable morbidities and tool to predict and avoid ineffective therapy
are lacking. Because deregulated proliferation is one of the hallmarks of cancer and its
proliferation rate is associated with aggressive biologic behavior and response to therapy,
imaging the proliferative state of cancer cells by noninvasive functional imaging is of
great interest. Recently 18F-FLT (3'deoxy33'-18F-fluorothymidine) has been reported as a
promising PET radiopharmaceutical for imaging cancer proliferation and has been validated in
several in vitro & in vivo models. However, only a few studies addressed its role in
depicting changes in cancer proliferation and assessing response to CRT, and none of these
studies have focused on esophageal cancer. We propose to conduct a pilot study to learn the
optimal FLT PET imaging timepoint during the early course of CRT that has the highest
predictive value for pathCR in patients with esophageal cancer.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Determine optimal timepoint during CRT that FLT-PET imaging can predict response
2 months
No
K.S. Clifford Chao, MD
Principal Investigator
Columbia University
United States: Food and Drug Administration
AAAD5444
NCT01065818
August 2009
August 2014
Name | Location |
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Columbia University Medical Center | New York, New York 10032 |