The Role of Direct Visual Fluorescence in Oral Examination
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.
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone
Will be evaluated by calculating sensitivity and specificity and their corresponding exact 95% confidence intervals. Association between the two techniques will be assessed using the simple kappa statistic.
At the time of examination
Kalmar John, DMD, PhD
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|