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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
John Kalmar, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01816841
First received: March 20, 2013
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Role of Direct Visual Fluorescence in Oral Examination

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone [ Time Frame: At the time of examination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 283
Study Start Date: November 2008
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Kalmar John    614-292-4250    kalmar.7@osu.edu   
Principal Investigator: Kalmar John         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Kalmar John, DMD, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: John Kalmar, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01816841     History of Changes
Other Study ID Numbers: OSU-08095, NCI-2012-02017
Study First Received: March 20, 2013
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Direct Visual Fluorescense
Oral Examination
oral cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Lip Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Lip Diseases
Mouth Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 20, 2014