Houston, Texas 77030


The goal of this clinical research study is to evaluate fluorescence imaging, widefield fluorescence imaging, point spectroscopy imaging methods, and or/ oral brush cytology that may help doctors monitor patients at an increased risk of developing an oral cancer, including those with pre-cancerous lesions in the mouth.

Study summary:

The Imaging Methods: All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Researchers have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence and also reflect light differently. Researchers need to better understand whether fluorescence and reflectance of light from tissues in the mouth can be used to tell whether areas of the mouth are abnormal. This information may help doctors detect pre-cancers and early cancer. Fluorescence Imaging: Researchers have developed instruments that shine different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light. This is an imaging system that takes fluorescence pictures through a portable head light. A second, handheld device, named the Identafi 3000, is similar in size and shape to a standard dental mirror. It uses white, violet, and amber light to highlight abnormal tissue areas. The users, wearing special filter eyeglasses, can evaluate and identify changes in the mouth. Widefield Fluorescence Imaging: This is an imaging system that takes fluorescence and reflectance pictures through a dental microscope. Different colors of light are used to shine in the mouth and pictures are taken using a digital camera. Researchers hope to study the pictures to better understand the differences in fluorescence from normal and abnormal cells. Point Spectroscopy System: This study may also test a technique called fluorescence and reflectance spectroscopy. Different colors of light are directed through fibers to the lining of the mouth and then light is collected and sent to a special camera and a computer to be analyzed. The spectroscopy system has a small probe about the size of a writing pen which is placed gently against the lining of the mouth. The exposed tissues will give off very small amounts of light called fluorescence. This light is not seen by the eye, but is seen by a computer. Brush Cytology: This is a method to analyze cells from the lining of the mouth. A brush is used to scrape cells from the mouth. The cells can then be stained and checked under a microscope for pre-cancerous changes. Study Procedures: If you agree to take part in this study, a researcher may use fluorescence and/or widefield fluorescence imaging instruments to take pictures of several areas in the mouth. Then, the researcher may gently place point spectroscopy probe on 1-4 normal-looking areas and 1-4 abnormal areas. Different colors of light will be shone on the lining of the mouth through the probe. The light that returns from the tissue is collected through the probe and recorded on the computer. Then the researcher may press a brush inside your mouth and rotate 5-10 times to collect cells. Researchers will record whether the doctor thinks the area is normal, abnormal but not suspicious for cancer, pre-cancer, or cancer. If your doctor thinks it is necessary, as per standard of care, a biopsy of abnormal areas may be performed. If any biopsies are performed, the information learned from the tissue will be compared with the imaging and spectroscopy data. These procedures should take about 20 minutes. Length of Study: You will be on study until you complete the 1-time imaging. If you agree to the optional procedures, you will be on study for as long as you continue to return to MD Anderson for clinic visits. This is an investigational study. Up to 300 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria: 1. Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia). 2. Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease. 3. Persons with any other condition (such as lichen planus, Fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development. 4. Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations Exclusion Criteria: 1. Subjects under the age of 18. 2. Subjects that are unable or unwilling to give informed consent.



Primary Contact:

Principal Investigator
Ann M. Gillenwater, MD
M.D. Anderson Cancer Center

Ann M. Gillenwater, MD
Phone: 713-792-6920

Backup Contact:


Location Contact:

Houston, Texas 77030
United States

There is no listed contact information for this specific location.

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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