Optical Imaging of Head and Neck Cancer
This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.
Squamous Cell Carcinoma
Head and Neck Cancer
Device: High Resolution Microendoscope
Device: Identafi 3000
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia|
- Accuracy and Interrate Reliability of HRME Image Interpretation [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]participants are imaged during their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment.
- Image Correlation with standard of care histopathology [ Time Frame: Following surgical resection - (day of enrollment or up to 2 weeks after enrollment.) ] [ Designated as safety issue: No ]participants are imaged after their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Squamous Cell Carcinoma
Patients with Head and Neck Squamous Cell Carcinoma undergoing surgical resection
swabbing the area to be imaged prior to tumor resection with .01% proflavine hemisulfate, a fluorescent dye. Will be placed on site for approximately 30-45 seconds.
Other Name: proflavine hemisulfateDevice: High Resolution Microendoscope
Use of this imaging system after application with proflavin
Other Name: HRMEDevice: Identafi 3000
use of this system to obtain optical images
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456143
|Contact: Andrew Sikora, MD, PhDfirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10017|
|Contact: Nadia Camille email@example.com|
|Principal Investigator: Andrew Sikora, MD, PhD|
|Principal Investigator: Brett A Miles, DDS MD FACS|
|Principal Investigator:||Andrew Sikora, MD, PhD||Mount Sinai School of Medicine|
|Principal Investigator:||Sharmila Anandasabapathy, MD||Mount Sinai School of Medicine|