NCT01456143

Optical Imaging of Head and Neck Cancer

In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sharmila Anandasabapathy, MD · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.

Detailed description

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.

Conditions

• Squamous Cell Carcinoma
• Neoplasia
• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	High Resolution Microendoscopy (HRME)	High Resolution Microendoscopy imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer.
OTHER	Proflavine hemisulfate	0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-10-20
• Last updated: 2018-02-01
• Results posted: 2016-06-14

Locations

1 site across 1 country: United States