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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01269190
Recruitment Status : Recruiting
First Posted : January 4, 2011
Last Update Posted : January 4, 2018
National Institutes of Health (NIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

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Detailed Description:

Researchers are looking for new ways to look at mouth lesions using different light colors and magnification. The devices in this study will be using different light colors that may help doctors to decide if a mouth lesion has a high risk of being cancerous.

Two (2) different kinds of devices are being used in this study. One type is designed to let researchers look at a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures. The devices used for this are the multi-spectral digital microscope (MDM), the Identafi 3000, and the portable screening system (PS2 or PS2.1)

The second type of imaging device that will be used in this study is designed to let researchers look at and take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at high magnification. This device is called the High-Resolution Microendoscope (HRME).

Also, a coloring substance (a fluorescent dye which glows green in the dark) will be painted on areas of the mouth with a cotton tip applicator to help improve the pictures.

Women who are able to become pregnant must have a negative blood (2 teaspoons) pregnancy test to participate in this study. Women who are breast feeding or nursing will not be eligible to participate in this study.

Mouth Exam:

If you agree to take part in this study, you will have a mouth exam. The study doctor will take pictures of any lesions inside the mouth. The pictures will be taken under a standard white light.

The study doctor will then take pictures of the inside of your mouth using one or more of the first type of imaging devices (the MDM, the Identafi 3000, and/or the PS2) depending on which device is available at that time. It should take about 1 minute to take all the pictures. "Normal" (non-lesion) tissue in your mouth may also be imaged.

The pictures taken with the MDM and/or the Identafi 3000, and/or the PS2 will be studied to better understand the use of different colors of light in mouth imaging.

A coloring substance (proflavine) will then be used to stain the mouth tissue, making it easier for the HRME to take pictures. Using a cotton swab, the study doctor will brush up to 2 lesions and 1 normal (non-lesion) area in the mouth with proflavine. After up to 30 seconds, the study doctor will again look at and take pictures of the same mouth areas with the MDM, and/or the Identafi 3000, and/or the PS2. Then a small probe (about the size of a pencil tip) on the HRME will be placed against the lesions and the normal area inside your mouth. Light from the end of the HRME probe will be used to take a picture of the stained tissue. The HRME procedure should take less than 1-2 minutes at each tissue site. You will then rinse your mouth with water or salt water after the procedures.

The mouth exam and any lesion imaging will all be done right before your scheduled surgery. The imaging will be performed in the operating room right after you have gone to sleep but before the start of your surgery. However, you may choose to have the imaging performed while you are awake. The whole procedure should not take more than 10 to 15 minutes. It is very unlikely that adding this amount of time under general anesthesia will cause you any extra risk.

Biopsies and Tissue Removal:

After all imaging is complete, you will have tissue biopsies on any lesions that were scanned, as well as the normal area that was scanned, to check if the tissue is cancerous or pre-cancerous. These study biopsies will be performed during your already-scheduled surgery while you are under general anesthesia (asleep). To collect a tissue biopsy, a small cutting tool will be used to remove tissue from the lesions. Each sample will be about 4 millimeters wide (about the size of a pencil eraser). These samples will only be used for the tests described here.

After the tissue biopsies are taken, the lesions will then be removed as part of your scheduled surgery. The clinical results of the tested biopsy samples will be compared to the pictures of the mouth tissue that were taken with the HRME and either the MDM and/or Identafi 3000 and/or the PS2.

You will not be told of any of the experimental findings of this study. However, the results will be available to your doctor.

All data (such as the tissue images and your diagnosis) will be coded with a number, instead of your personal identifying information (such as your name or medical record number), to help ensure your privacy.

Length of Study:

The imaging and tissue removal take around 10 to 15 minutes. After the tissue biopsies are complete, your active participation in the study will be over. Researchers may contact you during your routine follow-up visits to see how you are doing and to check if you have had any problems from the imaging procedures. You may also be contacted by telephone or e-mail by research personnel for up to 3 months.

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

Resource links provided by the National Library of Medicine

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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its 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
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Study Chair: Ann M. Gillenwater, MD, BA M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01269190     History of Changes
Other Study ID Numbers: 2008-0613
NCI-2015-01904 ( Registry Identifier: NCI CTRP )
First Posted: January 4, 2011    Key Record Dates
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
Oral Neoplasia
oral dysplasia
oral lesions
Wide-Field In Vivo Imaging
High Resolution In Vivo Imaging
Topical Fluorescent Dyes
contrast dye
surgical resection
High Resolution Microendoscope
Identafi 3000
Multispectral Digital Microscope
Portable Screening System

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Anti-Infective Agents, Local
Anti-Infective Agents