Hyperspectral Imaging-Based Multimode Dermoscope For Early Melanoma Detection

DESCRIPTION provided by applicant Melanoma the fastest growing cancer worldwide kills more than one person every hour in the United States and costs more than $ billion per year Yet if detected at an early stage it can be easily cured with a tenfold improvement in survival rate and a hundredfold reduction in treatment cost Current methods have not yielded the breakthroughs needed either because they are too simple visual examination of skin with or with out digital imaging or because the required high sensitivity comes at the expense of lowered specificity even in emerging advanced methods What is necessary to address these unmet needs is a more sophisticated approach We propose such an approach based on analysis of the current state of the art in melanoma diagnosis and feedback from clinicians as well as concepts from the well established field of risk management We concluded that a combination of several imaging methods is needed brought together onto the same instrument in a synergetic multimode set Under other funding we developed a research prototype multimode dermoscope with powerfully diagnostic hyperspectral imaging as its central method This proposal outlines how we plan to turn this device SkinSpect into a useful clinical tool for better earlier and more reliable diagnosis of melanoma The entire Spectral Molecular Imaging Inc SMI team has the extensive experience needed and will be joined by prestigious groups at University of California Irvine Beckman Laser Institute and Memorial Sloan Kettering Cancer Center bringing valuable expertise contributions in key areas Our diagnostic instrument combines hyperspectral polarization and fluorescence imaging of pigmented skin lesions nevi integrated in a high resolution non invasive dermoscopic imaging system We can extract three dimensional physiological and morphological diagnostic measures including lesion depth Breslow thickness and the concentration and distribution of skin nevus components such as melanin collagen and oxy deoxy hemoglobin We will focus on the accuracy with which we can quantitate features important for lesion modeling and diagnosis with emphasis on improving specificity Building on our previously developed research prototype we will manufacture and technically validate an improved clinical prototype Phase I and will evaluate this system in three clinical trials Phase II We will characterize the system with tissue phantoms test algorithms for compositional mapping and human volunteers build SkinSpect clinical prototypes under FDA type tight design controls optimize comprehensive tissue analysis software using clinical trial data demonstrate relative efficacy of each of the imaging modes including some competing ones versus our full multimode combination The desired overall outcome is a truly advanced yet cost effective instrument to be adopted by clinicians fighting melanoma for saving lives productivity and costs PUBLIC HEALTH RELEVANCE Melanoma is a serious cancer eliciting an unacceptably high price in lives one person per hour in the US productivity lost and treatment costs An advanced high tech approach to its best management early detection is needed and we have created one by bringing several methods including one developed for satellite imaging into a single instrument a multimode imaging device for skin examination and analysis Spectral Molecular Imaging Inc has developed advanced approaches to characterize skin lesions has solved problems that have prevented prior devices from accurately measuring tissue composition and has put together a very strong multi site team to carry out commercialization in a small business driven industrial academic clinical collaboration