In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
The purpose of this study is to determine if optical imaging modalities used at the time of
surgical resection for head and neck squamous cell carcinoma can help delineate normal from
cancerous mucosa. The High resolution microendoscope, developed by our collaborators at Rice
university, can allow for real time visualization of tissue nuclei. The overall aim of this
study is to determine if this device can be used to enhance the accuracy of intraoperative
margin detection during tumor resection for head and neck cancer.
At the time of tumor resection for head and neck squamous cell carcinoma, a wide field
imaging device will be used to identify suspicious areas. The High resolution device will
then image representative areas from the tumor, the tumor margin, and normal mucosa. A
topical dye, proflavin, will be placed on the tissue to enhance the visualization of nuclei
prior to imaging with the HRME device. Following imaging, biopsies of the imaged areas will
be taken and submitted for pathology diagnosis. The images of the biopsies will then be
compared and the device will be evaluated for accuracy of margin detection at the time of
tumor resection.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Accuracy and Interrate Reliability of HRME Image Interpretation
participants are imaged during their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment.
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
No
Andrew Sikora, MD, PhD
Principal Investigator
Mount Sinai School of Medicine
United States: Food and Drug Administration
09-2057
NCT01456143
December 2011
September 2013
Name | Location |
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Mount Sinai School of Medicine | New York, New York 10029 |