High-speed, portable reflectance confocal microscope (pRCM) for imaging skin cancer

项目总结/文摘

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. Once biopsied tissue is removed from a patient, the biopsy specimen is transported to an off-site laboratory for processing and staining. Finally, a pathologist renders a diagnosis by analyzing the specimen under microscopy. 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) has been shown to improve skin cancer diagnosis without a biopsy, but its impact has been confined to ~63 tertiary and teaching hospitals in the US. RCM is the only FDA-cleared imaging method that can non-invasively examine cellular details. In 2017, RCM was granted CPT reimbursement codes, which is incentivizing healthcare providers to adopt RCM in their practices. However, widespread adoption has not occurred mainly due to the following weaknesses: high device cost (~$100,000), non-portability (cart-based), and slow imaging speed (6-9 frames/sec (fps), which can prolong the RCM imaging to 15 minutes and disrupt the existing clinical workflow). Our overarching goal is to develop a low-cost, portable RCM (pRCM) device and make non-invasive, rapid skin cancer diagnostics accessible in most clinical settings. In a previous R21 project, Dr. Kang (PI, University of Arizona) invented the world’s first smartphone-based, pRCM device. We demonstrated pRCM imaging of skin cancers in Uganda and Arizona. In 2019, ArgosMD was formed to commercialize the pRCM technology, and signed an exclusive licensing agreement with the University of Arizona. Our projected commercial pRCM device will provide three unique strengths over the current RCM: low device cost ($2,000), portability (pen-sized), and fast imaging (203 fps). These strengths will enable pRCM penetrate a wide range of clinical settings (e.g., dermatology, primary care, rural and retail clinics) and enable non-invasive, real-time diagnosis of skin cancers in these settings. In this STTR Phase I project, we aim to develop a new and improved pRCM device with 20 times faster imaging speed than current RCM devices. We will achieve this goal through following specific aims: Aim 1: Develop a high-speed pRCM device. We will significantly increase the pRCM imaging speed by developing a novel speckle-modulated illumination optics. Aim 2: Evaluate high-speed pRCM by imaging skin lesions in vivo. Twenty lesions suspicious for skin cancer will be imaged with the pRCM device and current RCM device to evaluate the image quality.