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

The Ohio State University

Status: Completed

Conditions: Lip and Oral Cavity Squamous Cell Carcinoma; Stage 0 Lip and Oral Cavity Cancer; Tongue Cancer; Oral Cavity Verrucous Carcinoma

Treatments: Procedure: fluorescence imaging; Procedure: examination; Procedure: Comparison of surgical margins by COE vs. DVFE; Procedure: biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01816841

NCI-2012-02017 (Registry Identifier)

OSU-08095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Diagnostic (COE and DVFE)- Arm I

Experimental group

Description:

Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.

Treatment:

Procedure: biopsy

Procedure: fluorescence imaging

Procedure: examination

Arm II - Comparison of surgical margins using COE vs. DVFE

Experimental group

Description:

Comparison of surgical margins using COE vs. DVFE

Treatment:

Procedure: Comparison of surgical margins by COE vs. DVFE

Procedure: biopsy

Procedure: fluorescence imaging

Procedure: examination