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

Not Applicable

Completed

• Conditions: Tongue Cancer; Oral Cavity Verrucous Carcinoma; Stage 0 Lip and Oral Cavity Cancer; Lip and Oral Cavity Squamous Cell Carcinoma
• Interventions: Procedure: fluorescence imaging; Procedure: biopsy; Procedure: examination; Procedure: Comparison of surgical margins by COE vs. DVFE

• Registration Number: NCT01816841
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2008-11-11
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-22
• Primary Completion: 2016-10-03
• Study Completion: 2019-12-28
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm II - Comparison of surgical margins using COE vs. DVFE	fluorescence imaging	Comparison of surgical margins using COE vs. DVFE
Arm II - Comparison of surgical margins using COE vs. DVFE	Comparison of surgical margins by COE vs. DVFE	Comparison of surgical margins using COE vs. DVFE
Diagnostic (COE and DVFE)- Arm I	biopsy	Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.
Diagnostic (COE and DVFE)- Arm I	examination	Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.
Arm II - Comparison of surgical margins using COE vs. DVFE	biopsy	Comparison of surgical margins using COE vs. DVFE
Arm II - Comparison of surgical margins using COE vs. DVFE	examination	Comparison of surgical margins using COE vs. DVFE
Diagnostic (COE and DVFE)- Arm I	fluorescence imaging	Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone	At the time of examination	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.
Differences between lesional margins identified by COE and DVFE	At the time of examination	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.

Trial Locations

Locations (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States