Optical Imaging of Head and Neck Cancer

Sharmila Anandasabapathy, MD

Status: Terminated

Conditions: Squamous Cell Carcinoma; Neoplasia; Head and Neck Cancer

Treatments: Device: High Resolution Microendoscopy (HRME); Other: Proflavine hemisulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01456143

GCO 09-2057

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

HRME with proflavine

Experimental group

Description:

High Resolution Microendoscopy (HRME) 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. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.

Treatment:

Other: Proflavine hemisulfate

Device: High Resolution Microendoscopy (HRME)