Trial Information

A Pilot Study: In Vivo Reflectance Confocal Imaging for Detection of Neoplasia of Oral Mucosa

The study will take place at M. D. Anderson. Examinations will be performed in the cancer
prevention, head and neck or dental clinics, or the operating room for patients who get
scheduled for surgery as part of their standard care.

Abnormal looking areas (lesions) inside the mouth may be a sign of cancer or changes that
may lead to cancer. Researchers are looking for a practical way to tell early on whether
these lesions are cancer or may become cancer. This study will look at a technique called
reflectance confocal imaging.

Participants in this study will have an examination of the mouth. A photograph will be taken
of any abnormal areas inside the mouth. Then a small probe, about the size of a large ink
pen, will be placed gently against one to two abnormal appearing areas, and one normal
appearing area inside the mouth. The probe will expose the oral lining to a small amount of
light. Some of this light will be reflected back into the probe, and be picked up by a
computer. Pictures will be made of the tissue.

A small amount of vinegar will be placed at each site with a cotton swab before the probe is
placed. The procedure takes about 1-2 minutes at each site. A small sample of tissue from
each site, both the normal and abnormal, will be removed. The biopsies done on the normal
tissue are done for this study only and are not part of standard care. The samples will be
removed either at the time of surgery or under local anesthesia in the clinic. Briefly,
the small areas to be biopsied will be numbed with topical anesthesia and an injection of
local anesthesia. Then a small amount of tissue, about as big as a pencil eraser, will be
removed with sterile surgical instruments. This should cause little discomfort or bleeding.
The tissue will be placed in a special fluid and then looked at with a special microscope.
The tissue samples will be examined with a microscope by a pathologist to learn if the
tissue is cancerous or precancerous. These results will be compared with the pictures that
were made of the lining of the mouth.

You will not be told of any of the experimental findings. The pathology review of the
tissue removed will be available to the treating physician for patient care.

THIS IS AN INVESTIGATIONAL STUDY. The device used for reflectance confocal imaging is an
investigational device. It is considered a non-significant risk device by the FDA to be used
for research only. A total of 22 patients will take part in this study. All will be
enrolled at M. D. Anderson.