Trial Information

Oral Tumor Margin Detection Using Optical Spectroscopy

Fluorescence and Reflectance:

All tissue and cells are made up of tiny particles that give off small amounts of light.
This light is called fluorescence. Cancerous cells and normal cells give off different
amounts and types of fluorescence and also reflect (bounce back) light differently.
Researchers want to better understand if fluorescence and reflectance from mouth tissue can
be used to tell which cells are abnormal. This information may help doctors detect early
mouth cancers and treat all areas affected by cancerous changes.

The MDM Instrument, FastEEM4 Instrument, POS Instrument, PS2 Instrument, and the IMS
Instrument:

Five (5) instruments have been developed:

- the multispectral digital microscope (MDM), a microscope that allows fluorescence and
reflectance to be collected;

- the FastEEM4, which can shine different colors of light on the mucosa (the lining of
the mouth), which allows fluorescence and reflectance to be collected and looked at
without surgically removing any tissue;

- the portable optical spectroscopy (POS) instrument, which is a smaller, portable
version of the FastEEM4 device;

- the portable screening system (PS2), which can take images and measurements both in
reflectance and in fluorescence mode; and

- the image mapping spectrometer (IMS), which is PS2 and POS combined.

The MDM system is a modified standard medical microscope similar to what doctors use to
examine people's ears. A special light source has been attached to this microscope to
provide different colors of light that can shine in the mouth. This microscope also has a
digital camera attached to it so that researchers can take pictures of fluorescence and
reflectance in the mouth in order to record what is seen with the different light colors.
Researchers want to study the pictures in order to better understand the differences in
fluorescence and reflectance from normal and abnormal cells.

The PS2 is an imaging device for examining the mouth without touching the mouth. The PS2
uses a blue light source in fluorescence mode. The light passes through a filter and shines
on the tissue area. A filter is placed in the path to collect only the fluorescent light
given off from the tissue. In reflectance mode, a white light is used. Images are
collected using a device and a laptop with a software interface. A set of fluorescence and
reflectance images can be taken in less than a minute.

The IMS is also an imaging device for examining the mouth without touching the mouth. The
IMS includes white and blue light, a camera lens, customized optics (mirror, prisms, and
lenses), a filter, a camera, and a computer. In reflectance mode, a white light shines on
the tissue area, and specialized optics put the data on the camera. In fluorescence mode,
the blue light highlights the tissue. A filter blocks the blue light, which allows tissue
fluorescence to be seen. The IMS uses the same light sources as the PS2.

The FastEEM4 system (nonstandard imaging technology) has a probe (a small device used for
measuring and/or detecting) that is about the size of a pencil. The probe is placed gently
against the mucosa, and different colors of light are directed through the probe to a small
area (the lesion and the normal-appearing area) of mouth tissue. Then the fluorescence and
reflectance is recorded by a computer.

The POS instrument will direct different colors of light 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 fluorescence. This light cannot be seen by the eye, but is seen by a computer.

Use of the MDM, PS2, or IMS Instruments:

If you agree to take part in this study, a clinician may first use the MDM, PS2, or
IMSsystem. If one of these systems are used, the clinician will examine the inside of your
mouth with a gloved finger while using standard white light or one or more of the imaging
systems for viewing. The instrument will then take pictures of abnormal-appearing and
normal-appearing areas in the mouth. The edge between these areas will then be marked with a
surgical pen to outline the border between the abnormal-appearing tissue and
normal-appearing tissue to be seen on a digital photo. Imaging with each device will take
about 2 minutes or less. Between each use of the instrument, it will be sterilized
according to standard practices.

Use of the FastEEM4 and/or POS Instruments:

The clinician may then use the FastEEM4 and/or the POS systems. If the FastEEM4 and/or POS
systems are used, you will have a FastEEM4 and/or POS probe(s) placed gently on the mouth
lesion(s). Several measurements will then be taken by moving the probe(s) a short distance
at a time, toward the edge of the lesion(s), until it measures what appears to be normal
mouth tissue.

Biopsies and Tissue Removal:

You may be having surgery to remove abnormal-appearing mouth lesions as part of standard
care, so the study biopsies and tissue removal may be done at the same time as your surgery.
After the surgeon has finished surgery and removed tissue from your mouth as part of your
standard treatment, a portion of tissue (from both the abnormal-appearing and
normal-appearing areas) that was already removed by the surgeon may be separated out from
the main tissue specimen and separately evaluated. This is done so that the researchers can
better compare the appearance and diagnosis at these sites to the images that were taken. In
addition, a biopsy may be taken from the area of normal-appearing tissue from the opposite
side of the mouth that was imaged with the FastEEM4 and/or POS probe(s), if the FastEEM4
and/or POS system(s) were used. If it is performed, this one biopsy of normal appearing
tissue will be in addition to what is removed for standard care.

If this biopsy is performed, a small sample (4 mm, about the size of a small pencil eraser)
of the lining of your mouth will be removed, while you are asleep under general anesthesia,
from the area of normal-appearing tissue from the opposite side of the mouth that was imaged
by both instruments.

Length of Study:

You will not be told of any experimental findings of this study. Information about the
diagnosis will be available to your treating doctor. After tissue collection is complete,
your participation in this study will be over.

All data (such as the tissue images and pathologic 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.

This is an investigational study. Up to 60 patients will take part in this study. All will
be enrolled at M. D. Anderson.