NCT01816841

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lip and Oral Cavity Squamous Cell Carcinoma
• Oral Cavity Verrucous Carcinoma
• Stage 0 Lip and Oral Cavity Cancer
• Tongue Cancer

Interventions

Type	Name	Description
PROCEDURE	fluorescence imaging	Undergo DVFE
PROCEDURE	biopsy	Undergo scalpel biopsy
PROCEDURE	examination	Undergo COE
PROCEDURE	Comparison of surgical margins by COE vs. DVFE	Surgical margin determination using DVFE

Timeline

• Start date: 2008-11-11
• Primary completion: 2016-10-03
• Completion: 2019-12-28
• First posted: 2013-03-22
• Last updated: 2020-01-30

Locations

1 site across 1 country: United States