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

To obtain data to evaluate whether multispectral digital imaging can assist clinicians to screen for premalignant lesions in the oral cavity. Our system will illuminate tissue with monochromatic light to excite fluorescence, and polarized white light to generate reflectance, exposing abnormalities for real time, clinical diagnosis. Primary Objectives: 1. To compare fluorescence images of oral mucosa lesions, obtained at 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images and pathologic analysis of biopsied tissue. 2. To compare reflectance images of oral mucosa lesion, obtained using broadband polarized light, to standard white light images and pathologic analysis of biopsied tissue. 3. To develop algorithms to discriminate between normal and abnormal tissue 4. To analyze images to determine which type of optical information (or combination thereof) yields the most diagnostically useful data

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Subjects with lesions of the oral cavity mucosa or suspicious for malignancy or premalignancy.
2. Subjects with the ability and willingness to sign an informed consent and authorization.
3. Subjects who develop new lesions or alterations in long-standing lesions are eligible, but not required, for re-examination with informed consent.

Exclusion Criteria:

1. Persons who are medically unfit to undergo superficial punch biopsies of oral mucosa.
2. Persons under the age of 18.