Proflavine: A Feasibility Study for In Vivo Imaging of Oral Neoplasia
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|ClinicalTrials.gov Identifier: NCT01269190|
Recruitment Status : Recruiting
First Posted : January 4, 2011
Last Update Posted : January 4, 2018
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.
This is an investigational study. The HRME, PS2, and MDM devices are not FDA approved or commercially available. Their use in this study is investigational. The Identafi 3000 is FDA approved and commercially available. Proflavine is not FDA approved or commercially available for use as a dye in the mouth. Its use in this study is investigational.
Up to 275 patients will take part in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Proflavine Procedure: Imaging Device: Widefield Multispectral Imaging Devices Device: High-Resolution Microendoscope (HRME)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||275 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study|
|Actual Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
- 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 ]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 ]Several images of oral cavity mucosa taking approximately two minutes or less each, and removal for pathologic analysis of the measured sites
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|