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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluorescence imaging
biopsy
examination
Comparison of surgical margins by COE vs. DVFE
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lip and Oral Cavity Squamous Cell Carcinoma focused on measuring Direct Visual Fluorescense, Oral Examination, oral cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Diagnostic (COE and DVFE)- Arm I

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

Arm Description

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

Comparison of surgical margins using COE vs. DVFE

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2013
Last Updated
January 29, 2020
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01816841
Brief Title
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
Official Title
The Role of Direct Visual Fluorescence in Oral Examination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 11, 2008 (Actual)
Primary Completion Date
October 3, 2016 (Actual)
Study Completion Date
December 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lip and Oral Cavity Squamous Cell Carcinoma, Oral Cavity Verrucous Carcinoma, Stage 0 Lip and Oral Cavity Cancer, Tongue Cancer
Keywords
Direct Visual Fluorescense, Oral Examination, oral cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (COE and DVFE)- Arm I
Arm Type
Experimental
Arm Description
Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.
Arm Title
Arm II - Comparison of surgical margins using COE vs. DVFE
Arm Type
Experimental
Arm Description
Comparison of surgical margins using COE vs. DVFE
Intervention Type
Procedure
Intervention Name(s)
fluorescence imaging
Intervention Description
Undergo DVFE
Intervention Type
Procedure
Intervention Name(s)
biopsy
Other Intervention Name(s)
biopsies
Intervention Description
Undergo scalpel biopsy
Intervention Type
Procedure
Intervention Name(s)
examination
Other Intervention Name(s)
Exam, Medical Assessment, Medical Exam, Medical Examination, Medical Inspection
Intervention Description
Undergo COE
Intervention Type
Procedure
Intervention Name(s)
Comparison of surgical margins by COE vs. DVFE
Intervention Description
Surgical margin determination using DVFE
Primary Outcome Measure Information:
Title
Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone
Description
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.
Time Frame
At the time of examination
Title
Differences between lesional margins identified by COE and DVFE
Description
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.
Time Frame
At the time of examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin McNamara, DDS, MS
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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