Trial Information

Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions

All tissue and cells are made of tiny particles that give off small amounts of light. This
light is called fluorescence. Scientists have learned that cancerous cells and normal cells
give off different amounts and different types of fluorescence. Scientists need to better
understand whether fluorescence from the oral cavity (mouth) can be used to tell which cells
are abnormal. This information can help doctors detect pre-cancers.

In order to better understand fluorescence, researchers at the Optical Spectroscopy and
Imaging Lab, Department of Bioengineering, Rice University have developed an instrument that
can collect and analyze fluorescence without surgically removing any tissue or touching the
tissue. This instrument takes pictures of oral cavity fluorescence through a microscope.
The instrument also takes regular live pictures. Scientists hope to study the pictures to
better understand the differences in fluorescence from normal and abnormal cells. The
instrument is a standard medical microscope similar to ones used by doctors in their offices
to examine people's ears. Researchers have attached a special light source to the
microscope that provides different colors of light. In addition, the microscope has a
digital camera attached to it so that the researchers can record what they see with the
different light colors.

In this study, a clinician will use the instrument to take pictures of suspicious and normal
oral cavity lesions. A small sample of the oral lesion (2-4 mm each, the size of a small
eraser) will be removed or biopsied from the areas that are imaged. A portion of both the
suspicious and normal areas will be taken to pathology for evaluation. The biopsy from the
normal appearing area is a biopsy that is additional to those you will receive as part of
your standard of care. Each participant will have 2-4 biopsies performed, depending upon
how many areas the examiner feels may be suspicious. Most people who take part in this
study will be having surgery to remove lesions in the oral cavity anyway, so the biopsies
will be performed at the time of surgery. For those participants who are not scheduled to
have surgery, the biopsies will be performed under local anesthesia in the clinic.

All data will be numerically coded to ensure your confidentiality.

In addition to the pictures taken and the biopsy, a brief interview will be performed by the
clinical research staff to discuss possible past local therapies and your personal history
of tobacco and alcohol use. The interview should take about 10 minutes to complete.

You will not be told of any of the experimental findings. Information confirming the
diagnosis will be made available to your treating physician. After this visit and tissue
collection, your participation in this study will be complete.

This is an investigational study. A total of 45 patients will take part in this study. All
will be enrolled at M. D. Anderson.