Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

The goal of this clinical research study is to evaluate fluorescence imaging (including a new handheld device), widefield fluorescence imaging, and/or point spectroscopy imaging methods that may help doctors monitor patients at an increased risk of developing an oral cancer, including those with pre-cancerous lesions in the mouth.

Objectives:

The overall objective of this exploratory study is to evaluate whether widefield multispectral imaging and/or point spectroscopy can assist in follow-up surveillance of patients with high risk for development of oral cancer including those with premalignant lesions in the oral cavity. Digital images obtained using various light wavelength combinations and spectroscopy of specific lesions will be used to examine patients at high risk for oral cancer during routine clinical follow-up examinations. Data will be correlated with standard clinical examination, development of dysplasia and invasive carcinoma, and pathological evaluation of biopsies when available.

The specific aims of the study are:

• To compare images of oral mucosa, obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.
• To assess whether the multispectral images and spectroscopic data provide any added benefit to assist clinicians in surveillance of high risk patients.

This will be an exploratory study designed to obtain images and/or spectroscopic data over time during routine follow-up surveillance of patients at high risk to develop oral cancer. We will investigate based on the following hypotheses:

1. The optical properties of epithelial tissue are altered due to biochemical and architectural changes occurring during malignant conversion. These alterations can be optically detected and used for diagnosis.
2. The human eye can better distinguish alterations in optical properties between non-neoplastic, dysplastic and malignant oral mucosa with the assistance of fluorescence and reflectance imaging.