ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01816841
Recruitment Status : Recruiting
First Posted : March 22, 2013
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Kristin McNamara, Ohio State University Comprehensive Cancer Center

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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 Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
  • Exam
  • Medical Assessment
  • Medical Exam
  • Medical Examination
  • Medical Inspection
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:
  • Exam
  • Medical Assessment
  • Medical Exam
  • Medical Examination
  • Medical Inspection
Procedure: Comparison of surgical margins by COE vs. DVFE
Surgical margin determination using DVFE


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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

Locations
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         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Kristin McNamara Ohio State University Comprehensive Cancer Center
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
The Jamesline  This link exits the ClinicalTrials.gov site

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