Proflavine: A Feasibility Study for In Vivo Imaging of Oral Neoplasia

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	275 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Actual Study Start Date :	December 2010
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm

Intervention/treatment

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.

Drug: Proflavine; 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 hemisulfate Procedure: 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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the Head & Neck area to remove or biopsy oral lesions will be eligible to participate in the study). Patients with previous treatment are eligible.
2. Ability to understand and the willingness to sign a written Informed Consent Document (ICD).

Exclusion Criteria:

1. Known allergy to proflavine or acriflavine.
2. Age less than 18 years.
3. Pregnant or nursing females.
4. The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Ann M. Gillenwater, MD, BA	713-792-8841

Locations

United States, Texas
University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Institutes of Health (NIH)

Investigators

Study Chair:	Ann M. Gillenwater, MD, BA	M.D. Anderson Cancer Center

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01269190 History of Changes
Other Study ID Numbers:	2008-0613; NCI-2015-01904 ( Registry Identifier: NCI CTRP )
First Posted:	January 4, 2011
Last Update Posted:	January 4, 2018
Last Verified:	January 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by M.D. Anderson Cancer Center:

oral mucosa in vivo; Wide-Field In Vivo Imaging; High Resolution In Vivo Imaging; Oral Neoplasia; Topical Fluorescent Dyes; contrast dye; oral dysplasia; Proflavine; oral lesions	surgical resection; High Resolution Microendoscope; HRME; Identafi 3000; Multispectral Digital Microscope; MDM; Portable Screening System; PS2

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms; Neoplasms by Site	Proflavine; Anti-Infective Agents, Local; Anti-Infective Agents