Diagnostic Aids for Detection and Diagnosis of Oral Cancer

Study Procedures:

Certain types of light may cause cells to give off a tiny amount of light (called
fluorescence). Researchers have learned that cancer cells and normal cells reflect light and
give off fluorescence differently. Researchers want to find out if different kinds of light
can be used to discover areas of the mouth that may have abnormal or cancerous cells.

If you agree to take part in this study, a researcher may use up to 3 types of imaging
instruments to take pictures and readings of several areas in your mouth.

- VELScope is an FDA approved handheld camera device that takes images of the mouth with
different colors of light. The VELScope shines blue light into the mouth, and pictures
are taken using a camera that is attached to the device.

- Widefield Fluorescence Imaging uses a non-contact imaging device similar to the
VELScope. It shines different colors of light and then takes pictures of the inside of
the mouth using a digital camera.

- Point Spectroscopy System uses a probe (about the size of a tip of a pen) that is
gently placed on several areas of the mouth. Different colors of light are directed
through optic fibers to the lining of the mouth, and the probe collects the light that
returns from the tissue and sends the information to a computer.

Researchers will record whether the doctors find any areas within your mouth that may not
appear completely normal. They will collect tissue samples of these abnormal areas using a
brush biopsy. To perform an oral brush biopsy, the research will press a small brush against
an area inside your mouth, and turn it 5-10 times. The areas that could be biopsied include
your gums, tongue, the roof of your mouth, the bottom of your mouth, or the inside of your
cheeks. Any cells collected from the inside of your mouth will be placed on slides to be
studied by the study team.

The samples being collected will only be used for this testing, and no leftover samples will
be kept by the research staff.

These procedures should take about 20 minutes total.

This is an investigational study. The VELScope is an FDA approved device and is commercially
available. Wide-field and point spectroscopy systems are not FDA approved and are only
authorized for research. Up to 500 participants will take part in this multicenter study. Up
to 250 will be enrolled at MD Anderson.

Inclusion Criteria:

1. Subjects 18 years and older who are willing to participate.

2. Persons presenting for: Physical or dental exams at outside health care centers OR
Research meetings/gatherings OR Subjects identified at MDACC who are not already
diagnosed with oral cancer or pre oral cancer: this includes patients with
malignancies other than oral cancer, and visitors and family members, attendees of
the HNS Oral Cancer Screening event who are willing to participate.

Exclusion Criteria:

1. Subjects with a current diagnosis of oral cancer.

2. Subjects under the age of 18. It is extremely unusual for children to develop oral
cancer, therefore data from persons younger than 18 may add unexpected variables
which could affect data analysis.

3. Subjects who are unable or unwilling to give informed consent.