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

• ClinicalTrials.gov Identifier: NCT01816841
• Recruitment Status: Active, not recruiting
• First Posted: March 22, 2013
• Last Update Posted: December 21, 2018
• Sponsor: Ohio State University Comprehensive Cancer Center
• Information provided by (Responsible Party): Kristin McNamara, Ohio State University Comprehensive Cancer Center

Tracking Information

• First Submitted Date: March 20, 2013
• First Posted Date: March 22, 2013
• Last Update Posted Date: December 21, 2018
• Actual Study Start Date: November 11, 2008
• Actual Primary Completion Date: October 3, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 21, 2013)

• 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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01816841 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

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

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Procedure: fluorescence imaging
  • Procedure: biopsy
  • Procedure: examination
• Experimental: Arm II - Comparison of surgical margins using COE vs. DVFE
  Comparison of surgical margins using COE vs. DVFE
  Interventions:

  • Procedure: fluorescence imaging
  • Procedure: biopsy
  • Procedure: examination
  • Procedure: Comparison of surgical margins by COE vs. DVFE

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 19, 2018): 68
• Original Estimated Enrollment (submitted: March 21, 2013): 283
• Estimated Study Completion Date: December 31, 2019
• Actual Primary Completion Date: October 3, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01816841
• Other Study ID Numbers: OSU-08095; NCI-2012-02017 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Kristin McNamara, Ohio State University Comprehensive Cancer Center
• Study Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kristin McNamara, DDS, MS; Ohio State University Comprehensive Cancer Center

• PRS Account: Ohio State University Comprehensive Cancer Center
• Verification Date: December 2018