Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
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ClinicalTrials.gov Identifier: NCT01816841 |
Recruitment Status
:
Recruiting
First Posted
: March 22, 2013
Last Update Posted
: April 6, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lip and Oral Cavity Squamous Cell Carcinoma Oral Cavity Verrucous Carcinoma Stage 0 Lip and Oral Cavity Cancer Tongue Cancer | Procedure: fluorescence imaging Procedure: biopsy Procedure: examination Procedure: Comparison of surgical margins by COE vs. DVFE | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 283 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | The Role of Direct Visual Fluorescence in Oral Examination |
Actual Study Start Date : | November 11, 2008 |
Estimated Primary Completion Date : | December 31, 2018 |
Estimated Study Completion Date : | December 31, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Diagnostic (COE and DVFE)- Arm I
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
Undergo DVFE
Procedure: biopsy
Undergo scalpel biopsy
Other Name: biopsies
Procedure: examination
Undergo COE
Other Names:
|
Experimental: Arm II - Comparison of surgical margins using COE vs. DVFE
Comparison of surgical margins using COE vs. DVFE
|
Procedure: fluorescence imaging
Undergo DVFE
Procedure: biopsy
Undergo scalpel biopsy
Other Name: biopsies
Procedure: examination
Undergo COE
Other Names:
Procedure: Comparison of surgical margins by COE vs. DVFE
Surgical margin determination using DVFE
|
- Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816841
Contact: Ohio State University Comprehensive Cancer Center | 1-800-293-5066 | Jamesline@osumc.edu | |
Contact: John Kalmar, DMD PhD | 614-292-6577 | kalmar.7@osu.edu |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Kristin McNamara | |
Principal Investigator: Kristin McNamara |
Principal Investigator: | Kristin McNamara | Ohio State University Comprehensive Cancer Center |
Additional Information:
Responsible Party: | Kristin McNamara, Principal Investigator, Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT01816841 History of Changes |
Other Study ID Numbers: |
OSU-08095 NCI-2012-02017 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | March 22, 2013 Key Record Dates |
Last Update Posted: | April 6, 2018 |
Last Verified: | April 2018 |
Keywords provided by Kristin McNamara, Ohio State University Comprehensive Cancer Center:
Direct Visual Fluorescense Oral Examination oral cancer |
Additional relevant MeSH terms:
Tongue Diseases Carcinoma Carcinoma, Squamous Cell Carcinoma, Verrucous Mouth Neoplasms Tongue Neoplasms Lip Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site Mouth Diseases Stomatognathic Diseases Lip Diseases |