Spots Global Cancer Trial Database for Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
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Trial Identification
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
Study ID: NCT01816841
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Contact Details
Name: Kristin McNamara, DDS, MS
Affiliation: Ohio State University Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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