Proflavine: A Feasibility Study for In Vivo Imaging of Oral Neoplasia
The goal of this clinical research study is to learn if new imaging devices can help doctors decide if a lesion in the mouth is pre-cancerous or cancerous. The new imaging devices use different colors of light in mouth imaging.
Head and Neck Cancer
Device: Widefield Multispectral Imaging Devices
Device: High-Resolution Microendoscope (HRME)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study|
- Feasibility Assessing Oral Mucosa In Vivo with Wide-field and High resolution Images using New Optical and Topically Contrast Agent [ Time Frame: 3 years for patient enrollment; patient participation 10 - 15 minute imaging and tissue biopsy procedure prior to surgery for removal of lesion ] [ Designated as safety issue: No ]Assessments: 1) Standard white light headlamp where clinical impression classified into "normal", "abnormal low risk", "abnormal high risk", or "cancer"; 2) Widefield multispectral imaging digital images before topical fluorescent dyes, and 3) digital images by a widefield multispectral imaging device &/or high-resolution optical system after topical dyes where images reviewed by investigators blinded to clinical impression and histopathology diagnosis, classify lesions as "suspicious" or "not suspicious"; and, 4) Histopathology based on biopsy samples used as gold standard.
- Number of subjects and lesions successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye [ Time Frame: 3 years for patient enrollment; patient participation 10 to 15 minute procedure including tissue biopsies done before surgery ] [ Designated as safety issue: No ]Several images of oral cavity mucosa taking approximately two minutes or less each, and removal for pathologic analysis of the measured sites
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Mouth Exam
Oral mucosa in vivo assessment with wide-field and high resolution images obtained using new optical imaging devices composed of cameras and microscopes, and with a topically administered contrast agent.
Swabbing of inside mouth with cotton-tip applicator soaked in 0.01% proflavine hemisulfate, a fluorescent dye which glows green in the dark, placed on proposed evaluation sites for up to 30 seconds.
Other Name: proflavine hemisulfateProcedure: Imaging
Imaging of inside mouth with multi-spectral digital microscope (MDM), the Identafi 3000, or portable screening system (PS2 or PS2.1) done first prior to swab with normal white light and second post swabbing of mouth with Proflavine at high magnification with High-Resolution Microendoscope (HRME).Device: Widefield Multispectral Imaging Devices
Widefield multispectral imaging device used for imaging inside mouth: the Multi-spectral digital microscope (MDM) and/or the Identafi 3000 handheld system, and/or portable screening system (PS2 or PS2.1) both before and after Proflavine swabbing.Device: High-Resolution Microendoscope (HRME)
High-resolution optical system used for imaging of inside mouth post proflavine application.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269190
|Contact: Ann M. Gillenwater, MD, BA||713-792-8841|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Chair:||Ann M. Gillenwater, MD, BA||M.D. Anderson Cancer Center|