A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer
The investigators will evaluate whether this technology can be used and also try to obtain
photoacoustic images and functional data (oxygen contents, blood vessel characteristics,
etc) of the uterine lining to assess its appearance in women with and without cancer of the
endometrium. Currently, it is difficult for physicians to know whether or not tumors of the
endometrium have invaded and spread to other organs without performing an extended surgery
called a staging operation (removal of the lymph nodes or glands that drain the uterus to
assess under the microscope whether or not the cancer has spread). Our long term goal is to
use this new photoacoustic (PA) technology to improve detection of occult metastatic
disease. Occult disease is defined as tumor which cannot be seen without the use of imaging
techniques. and possibly avoid the need of extended operations. All of this could result in
better care for patients with endometrial cancer and other gynecologic problems.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Feasibility of using the device to image endometrial cancer
Feasibility of using this novel device to image endometrial cancer is our primary objective. The frequency of success in obtaining images, overall and per group, will be presented and binomial success rates with 95% confidence interval estimates will be calculated. Besides the overall success rates, graphical and tabular summaries of the feasibility across patient demographic and clinical characteristics will be created.
12 months or less
Yes
Israel Zighelboim, MD
Principal Investigator
Washington University School of Medicine
United States: Food and Drug Administration
201102405
NCT01498237
January 2012
December 2012
Name | Location |
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Washington University School of Medicine | Saint Louis, Missouri 63110 |