Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care

PRIMARY OBJECTIVES:

I. To assess the diagnostic benefit of the VELscope (direct visual fluorescence) inspection
in oral examination.

II. Efficacy of the VELscope in identifying dysplastic (premalignant) and malignant oral
mucosal lesions and in discriminating these lesions from common benign tissue changes.

III. Accuracy of clinical judgment versus VELscope findings. IV. Ability of the VELscope to
identify lesions or extent of lesions beyond what is clinically apparent.

OUTLINE:

Patients undergo conventional oral examination (COE) followed by direct visual fluorescence
examination (DVFE). Patients with tissue abnormalities found by COE or DVFE undergo scalpel
biopsy within 2 weeks.

Inclusion Criteria:

- HIGH-RISK POPULATION:

- 33 consecutive consenting patients presenting to The Ohio State University James
Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior
biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ
(CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting
for initial evaluation for treatment planning and/or presenting for follow-up
appointments monitoring for recurrence will be eligible to participate

- GENERAL POPULATION:

- 250 consecutive consenting patients presenting to The Ohio State University College of
Dentistry for routing dental care will be recruited; adult patients presenting to the
screening clinic for initial oral evaluation will be eligible to participate