Optical Imaging of Head and Neck Cancer
Squamous Cell Carcinoma - Neoplasia - Head and Neck Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
Squamous Cell Carcinoma, Neoplasia, Optical imaging, Head and Neck Cancer, Oropharynx, Larynx, Oral Cavity
Study Type
Study Phase
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Proflavine Type: Drug
Name: High Resolution Microendoscope Type: Device
Name: Identafi 3000 Type: Device
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx, hypopharynx

- Must be receiving surgical treatment for their cancer

Exclusion Criteria:

- Presence of medical or psychiatric condition affecting the ability to give informed consent

- Known allergy to Proflavin

- Pregnant or nursing Females
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Status: Recruiting
Contact: Nadia Camille - nadia.camille@mountsinai.org
Start Date
December 2011
Completion Date
September 2013
Sharmila Anandasabapathy
Icahn School of Medicine at Mount Sinai
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page