LED Dental's VELscope Vx will be utilized in a large-scale University of British Columbia (UBC) clinical trial designed to document the ability of tissue fluorescence visualization (FV) technology to increase the efficacy of surgery to remove oral cancers.
Internationally recognized for its work in applying FV technology in the lungs, cervix, skin, and oral cavity, UBC has shown that FV devices can identify both occult and clinically visible premalignant and malignant lesions. In a recent, small scale, retrospective study, UBC researchers documented that FV helped surgeons determine the extent of the high-risk FV field surrounding oral cancer and achieve remarkably lower two-year recurrence rates (0% for FV-guided surgery versus 25% for those without the FV-guided approach).
The upcoming study reflects the need for a larger-scale prospective, randomized controlled (phase III) trial to gather strong evidence of the efficacy of FV-guided surgery. Researchers will assess the ability of FV-guided surgery to reduce the recurrence rate of the cancer, cost-effectively improve the quality of life of oral cancer patients, and spare healthy tissue while increasing the capture of high-risk tissue.
The study will involve 200 patients diagnosed with severe dysplasia, carcinoma in situ, or invasive squamous cell carcinoma; 100 will have FV-guided surgery, and 100 will have surgery that is not FV-guided.
In addition to UBC, more than 10 other universities, hospitals, and institutions throughout Canada will be involved in the study. The study is expected to be completed in June 2015.
