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.

项目摘要/摘要 当前的皮肤癌诊断，活检，侵入性，缓慢且成本的护理标准。皮肤 癌症是美国最常见的癌症。可疑皮肤病变的活检是关键步骤 皮肤癌诊断。每年在美国进行15-2000万次皮肤活检。一旦活检组织是 从患者中移除，活检标本被运送到现场实验室进行处理和 染色。最后，病理学家通过在显微镜下分析样品来提供诊断。这个过程 医疗保健系统的成本是侵入性，缓慢和朴素的。诊断可能需要多达2-4 几周，随后的访问延迟治疗，增加了身体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。 反射率共聚焦显微镜（RCM）已显示可改善皮肤癌的诊断，而无需活检， 但是，它的影响仅限于美国的大约63个三级和教学医院。 RCM是唯一已清除的FDA 成像方法可以非侵入性检查细胞细节。 2017年，RCM被授予CPT 报销代码，它激励医疗保健提供者在其实践中采用RCM。然而， 宽度采用尚未发生，主要是由于以下弱点：高设备成本（约100,000美元）， 不通用性（基于推车）和慢成像速度（6-9帧/秒（FPS），可以延长RCM 成像为15分钟，并破坏现有的临床工作流程）。 我们的总体目标是开发低成本的便携式RCM（PRCM）设备，并使无创， 在大多数临床环境中可以使用快速皮肤癌诊断。在以前的R21项目中，康博士（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。我们证明了PRCM 乌干达和亚利桑那州皮肤癌的成像。在2019年，ArgoSMD成立以商业化PRCM 技术，并与亚利桑那大学签署了独家许可协议。我们的预计 商业PRCM设备将在当前RCM上提供三种独特的优势：低设备成本（$ 2,000）， 可移植性（笔大小）和快速成像（203 fps）。这些优势将使PRCM穿透广泛的范围 临床环境（例如皮肤病学，初级保健，粗糙和零售诊所），并实现非侵入性实时 在这些情况下诊断皮肤癌。 在此STTR I阶段项目中，我们旨在开发一种更快的新的和改进的PRCM设备 成像速度比当前的RCM设备。我们将通过遵循特定目标来实现这一目标： AIM 1：开发高速PRCM设备。我们将大大提高PRCM成像速度 开发一种新型的斑点调节光学器件。 AIM 2：通过在体内成像皮肤病变来评估高速PRCM。二十个病变可疑皮肤癌 将使用PRCM设备和当前RCM设备成像，以评估图像质量。