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The Role of Direct Visual Fluorescence in Oral Examination


N/A
18 Years
N/A
Open (Enrolling)
Both
Healthy Volunteers, Lip and Oral Cavity Squamous Cell Carcinoma, Oral Cavity Verrucous Carcinoma, Stage 0 Lip and Oral Cavity Cancer, Tongue Cancer

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Trial Information

The Role of Direct Visual Fluorescence in Oral Examination


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone

Outcome 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.

Outcome Time Frame:

At the time of examination

Safety Issue:

No

Principal Investigator

Kalmar John, DMD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

OSU-08095

NCT ID:

NCT01816841

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Healthy Volunteers
  • Lip and Oral Cavity Squamous Cell Carcinoma
  • Oral Cavity Verrucous Carcinoma
  • Stage 0 Lip and Oral Cavity Cancer
  • Tongue Cancer
  • Direct Visual Fluorescense
  • Oral Examination
  • oral cancer
  • healthy, no evidence of disease
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Mouth Neoplasms
  • Tongue Neoplasms
  • Carcinoma, Verrucous
  • Lip Neoplasms

Name

Location
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240