Optical Imaging of Head and Neck Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-07-31

Brief Summary

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

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Detailed Description

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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

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Squamous Cell Carcinoma Neoplasia Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRME with proflavine

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.

Group Type EXPERIMENTAL

High Resolution Microendoscopy (HRME)

Intervention Type DEVICE

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.

Proflavine hemisulfate

Intervention Type OTHER

0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa

Interventions

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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.

Intervention Type DEVICE

Proflavine hemisulfate

0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa

Intervention Type OTHER

Other Intervention Names

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HRME Proflavine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No