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

The Role of Direct Visual Fluorescence in Oral Examination

This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.

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