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

Tongue Cancer Clinical Trial

Official title:

The Role of Direct Visual Fluorescence in Oral Examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816841
• Other study ID #: OSU-08095
• Secondary ID: NCI-2012-02017
• Status: Completed
• Phase: N/A
• Start date: November 11, 2008
• Est. completion date: December 28, 2019

Study information

• Verified date: January 2020
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 28, 2019
• Est. primary completion date: October 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• fluorescence imaging
Undergo DVFE
• biopsy
Undergo scalpel biopsy
• examination
Undergo COE
• Comparison of surgical margins by COE vs. DVFE
Surgical margin determination using DVFE

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   The Jamesline