Mini-reflectance confocal microscope (Mini-RCM) for aiding skin cancer diagnosis and treatment

Project Summary/Abstract The current standard of care for skin cancer diagnosis, biopsy, is invasive, slow, and burdensome in cost. Skin cancer is the most commonly diagnosed cancer in the US. Biopsy of suspicious skin lesion is the key step of skin cancer diagnosis. 15-20 million skin biopsies are performed in the US annually. The biopsied tissue is processed as histologic slides and examined by a pathologist. This process is invasive, slow, and burdensome in cost for the healthcare system. A diagnosis can take as many as 2-4 weeks, which delays treatment upon a subsequent visit, increasing physician utilization and patient wait times. Additionally, the majority of the biopsies are determined to be benign, causing unnecessary cost and morbidity. Reflectance confocal microscopy (RCM) is the only FDA-cleared imaging method that can non-invasively examine cellular details. RCM is already making clinical impacts: 1) reducing unnecessary biopsy of benign lesions, 2) enabling treatment at the first clinic visit, and 3) monitoring non-invasive treatment. In 2017, RCM was granted CPT reimbursement codes, which is incentivizing healthcare providers to adopt RCM in their practices. However, its adoption has been limited to ~63 tertiary and teaching hospitals in the US due to the following weaknesses: high device cost (~$100,000), non-portability (cart-based), and slow imaging speed (6-9 frames/sec (fps), which prolongs the RCM imaging to 15 minutes and disrupt the existing clinical workflow. Our overarching goal is to develop a low-cost, non-invasive microscopy tool termed mini-reflectance confocal microscopy (Mini-RCM) for aiding skin cancer diagnosis and treatment in a wide range of healthcare settings. Over the past six years, Dr. Kang(PI)’s lab at UArizona has pioneered low-cost RCM technologies. By using a simple but powerful approach of using diffraction gratings and line illumination, we reduced the material cost of RCM to $4,000-5,000, while achieving comparable resolution to that of the high-cost, standard RCM devices. In 2019, ArgosMD was formed to commercialize the low-cost RCM technology, and signed an exclusive licensing agreement with UArizona. Recently, ArgosMD and UArizona successfully carried out an NCI STTR Phase I project to develop a low-cost RCM prototype that demonstrated the unprecedented imaging speed of 107 frames/sec (12-18 times faster than standard RCM devices). The fast speed enables rapid examination of multiple skin lesions, a critical feature to be integrated as part of the clinical workflow. In this STTR Phase I project, we aim to develop a new and improved Mini-RCM device with the widefield imaging capability and with the size and weight similar to those of a dermatoscope, an imaging tool universally used for dermatologic care. The improvements in Mini-RCM will make it ready for evaluation at multiple clinical settings in the Phase II study. We will develop the Mini-RCM device (Aim 1) and evaluate its performance by imaging skin lesions in vivo (Aim 2). We are an industry-academia, inter-disciplinary research team with expertise in optical engineering, dermatology, and computer science.