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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of Direct Visual Fluorescence in Oral Examination

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

Intervention / Treatment
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* Procedure: fluorescence imaging
* Procedure: biopsy
* Procedure: examination
* Procedure: Comparison of surgical margins by COE vs. DVFE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (COE and DVFE)- Arm I<br>Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks. | Procedure: fluorescence imaging<br>* Undergo DVFE<br>Procedure: biopsy<br>* Undergo scalpel biopsy<br>* Other names: biopsies;Procedure: examination<br>* Undergo COE<br>* Other names: Medical Inspection;|
| Experimental: Arm II - Comparison of surgical margins using COE vs. DVFE<br>Comparison of surgical margins using COE vs. DVFE | Procedure: fluorescence imaging<br>* Undergo DVFE<br>Procedure: biopsy<br>* Undergo scalpel biopsy<br>* Other names: biopsies;Procedure: examination<br>* Undergo COE<br>* Other names: Medical Inspection;Procedure: Comparison of surgical margins by COE vs. DVFE<br>* Surgical margin determination using DVFE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Differences between lesional margins identified by COE and DVFE | Will be evaluated using the dependent t-test. In the event that the parametric requirements of this test are not met, the Wilcoxon, matched-pairs, signed-ranks test will be used. | At the time of examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct Visual Fluorescense, Oral Examination, oral cancer