Grant: Proof of Principle Program - Phase II

Skin cancer is the most common cancer and the rates are continuing to rise at a staggering 3% per year. One in seven Canadians will develop a skin cancer during their lifetime. Over 3.5 million cases are diagnosed annually in the USA. The American Cancer Society estimates that about 68,130 new melanomas will be diagnosed in the United States during 2010. Melanoma is lethal in 85% of cases after metastasis. However, when diagnosed very early, survival rate can be 99% - highlighting the need for sensitive screening and early detection. Currently identification of melanomas is an art best performed by trained dermatologists. The definitive diagnosis ultimately requires excision of the suspect lesion, an undesirable and in many cases not practical solution especially in individuals with many suspect lesions. Hence there is a need for a device that can rapidly screen and distinguish melanomas from other more benign lesions. We have developed a technology called laser-Raman spectroscopy that measures molecular vibrations of skin tissue in vivo. The obtained optical signals can be used to derive biochemical information of the skin site measured. These biochemical information changes with malignancy transformation. Therefore, it can be used for accurate non-invasive melanoma detection. We have collected clinical data with this device from more than 912 skin lesions and an intermediate analysis has demonstrated great potential of this device for melanoma detection (diagnostic sensitivity of close to 100%, while still maintaining a false positive rate of only ~30%). The objectives of this project are (1) to conduct a detailed data analysis of the 912+ lesion spectral database to confirm the clinical utility and diagnostic accuracy of our new technology for melanoma/skin cancer detection and (2) to develop a simplified, optimized, and cost-effective, clinical device to facilitate next phase multi-centre clinical trials and subsequent commercialization.