Completed

The Role of Direct Visual Fluorescence in Oral Examination

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What is being tested

fluorescence imaging

+ biopsy

+ examination

Procedure
Who is being recruted

Carcinoma+10

+ Carcinoma, Squamous Cell

+ Head and Neck Neoplasms

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: November 2008
See protocol details

Summary

Principal SponsorOhio State University Comprehensive Cancer Center
Last updated: January 30, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: November 11, 2008

Actual date on which the first participant was enrolled.

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.

NCT01816841
Principal SponsorOhio State University Comprehensive Cancer Center
Last updated: January 30, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaCarcinoma, Squamous CellHead and Neck NeoplasmsStomatognathic DiseasesMouth DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialTongue DiseasesSquamous Cell Carcinoma of Head and NeckMouth NeoplasmsTongue Neoplasms

Criteria

4 inclusion criteria required to participate
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
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
HIGH-RISK POPULATION

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.

Group II

Experimental
Comparison of surgical margins using COE vs. DVFE

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, United StatesOpen Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center in Google Maps
CompletedOne Study Center