Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

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.