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

用于皮肤癌成像的高速便携式反射共焦显微镜 (pRCM)

• 批准号: 10381884
• 负责人: Dongkyun Kang
• 金额: $ 39.82万
• 依托单位: ARGOSMD, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10381884
• 关键词: Accreditation; Address; Adopted; Adoption; Agreement; Arizona; Benign; Biopsy; Biopsy Specimen; Cancer Diagnostics; Cellular Phone; Cervical; Clinic; Clinical; Clinical Research; Code; Current Procedural Terminology; Dermatologic; Dermatology; Devices; Diagnosis; Electronics; Financial Hardship; Goals; Grant; Health Care Costs; Health Personnel; Healthcare Systems; Image; Image Analysis; Imaging Device; Incentives; Laboratories; Lasers; Lesion; Licensing; Lighting; Malignant Neoplasms; Measures; Microscope; Microscopy; Monitor; Morbidity - disease rate; Motion; Optics; Pathologist; Patients; Performance; Phase; Physicians; Primary Health Care; Process; Reader; Rural; Scanning; Site; Skin; Skin Cancer; Small Business Technology Transfer Research; Source; Specimen; Speed; Stains; Teaching Hospitals; Technology; Time; Tissues; Training; Uganda; United States Centers for Medicare and Medicaid Services; Universities; Visit; Wait Time; accurate diagnosis; base; cancer diagnosis; cancer health disparity; cost; imaging modality; improved; in vivo; microscopic imaging; novel; portability; prevent; reflectance confocal microscopy; sensor; skin lesion; standard of care; success

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.

项目概要/摘要 目前皮肤癌诊断的护理标准（活检）是侵入性的、缓慢的且成本高昂。 癌症是美国最常诊断的癌症，对可疑皮肤病变进行活检是关键步骤。 美国每年进行 15-2000 万次皮肤活检。 从患者体内取出活检标本后，将其运送到场外实验室进行处理和 最后，病理学家通过在显微镜下分析标本来做出诊断。 对于医疗保健系统来说，这种方法是侵入性的、缓慢的且成本高昂，一次诊断可能需要 2-4 个人的时间。 数周，这会延迟后续就诊时的治疗，增加医生的利用率和患者的等待时间。 此外，大多数活检被确定为良性，导致不必要的成本和发病率。 反射共焦显微镜 (RCM) 已被证明可以在无需活检的情况下改善皮肤癌的诊断， 但其影响仅限于美国约 63 家三级医院和教学医院，RCM 是唯一一家获得 FDA 批准的医院。 可以非侵入性检查细胞细节的成像方法，2017年，RCM获得了CPT。 报销代码，这激励医疗保健提供者在其实践中采用 RCM 然而， 尚未广泛采用主要是由于以下缺点：设备成本高（约 100,000 美元）， 不便携（基于推车），成像速度慢（6-9 帧/秒 (fps)），这会延长 RCM 成像时间长达 15 分钟并扰乱现有的临床工作流程）。 我们的首要目标是开发一种低成本、便携式 RCM (pRCM) 设备，并使非侵入性、 在之前的 R21 项目中，Kang 博士（PI， 亚利桑那大学）发明了世界上第一个基于智能手机的 pRCM 设备。 2019 年，ArgosMD 成立，致力于将 pRCM 商业化。 技术，并与亚利桑那大学签署了独家许可协议。 商用 pRCM 设备将比当前 RCM 提供三个独特的优势：设备成本低（2,000 美元）、 便携性（笔大小）和快速成像（203 fps）这些优势将使 pRCM 能够渗透到更广泛的范围。 临床环境（例如皮肤科、初级保健、农村和零售诊所）并实现非侵入性、实时 在这些环境中诊断皮肤癌。 在这个 STTR 第一阶段项目中，我们的目标是开发一种新的和改进的 pRCM 设备，速度提高 20 倍 成像速度高于当前的 RCM 设备，我们将通过以下具体目标来实现这一目标： 目标1：开发高速pRCM设备，我们将显着提高pRCM成像速度。 开发一种新型散斑调制照明光学器件。 目标 2：通过对 20 个疑似皮肤癌的病变进行体内成像来评估高速 pRCM。 将使用 pRCM 设备和当前 RCM 设备进行成像以评估图像质量。