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Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

18 Years
Open (Enrolling)
Oral Cancer

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Trial Information

Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

Abnormal-looking areas (lesions) inside the mouth may be a sign of cancer or changes that
may lead to cancer. These lesions may need to be removed. Researchers are looking for a
practical way to tell early on whether these lesions are cancer or may become cancer. This
study will test a technique called fluorescence spectroscopy, which is under research in
this study.

Each patient may have 1 to 5 lesions and several normal-looking areas inside the mouth
exposed to a beam of light. The exposed tissues may emit very small amounts of light called
fluorescence. This light is not seen by the eye but is detected by a computer. The small
areas exposed to the light beam may then be removed.

The patients who need surgery may have the small tested areas removed when the lesions are
surgically removed. A small sample from a normal-looking area may also be removed during
surgery. Patients who do not need surgery may simply have small samples taken from the
lesions and a normal-looking area in the clinic rather than in the operating room. The
tissues will be looked at under a microscope to see whether they are cancerous. These
results will be compared with the spectroscopy results.

If you are scheduled to participate in another M. D. Anderson study, Protocol 2008-0137
Entitled, "Phase Ib Study of Erlotinib Prior to Surgery in Patients with Head and Neck
Cancer" (Study Chair: Dr. William William), some of your collected tissue samples may be
shared with Dr. William for use on 2008-0137.

This is an investigational study. About 262 patients will be consented and screened for
this study, with about 255 to take full part in this study. All will be treated at M. D.

Inclusion Criteria:

Any person 18 years of age or older with a lesion of the oral mucosa. Persons with
changes in existing lesions or those who develop new lesions can be re-evaluated, but it
is not required.

Exclusion Criteria:


Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Classification of Oral Lesions

Outcome Description:

Distinguishing between normal and abnormal sites with four lesion classifications of normal, non-malignant inflammatory, dysplasia, and neoplasia.

Outcome Time Frame:

11 Years

Safety Issue:


Principal Investigator

Ann M. Gillenwater, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Oral Cancer
  • Oral Mucosa Lesions
  • Oral Cancer
  • Neoplasia and Dysplasia in oral cavity mucosa
  • Fluorescence Spectroscopy
  • Reflectance Spectroscopy
  • Pre-cancerous lesions
  • Cancerous lesions
  • Mouth
  • Mouth Neoplasms
  • Lip Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030