Simultaneous coaxial widefield imaging and reflectance confocal microscopy for improved diagnosis of skin cancers in vivo

同时同轴宽场成像和反射共焦显微镜可改善皮肤癌的体内诊断

基本信息

批准号：
10372929
负责人：
Octavia Irma Camps
金额：
$ 63.79万
依托单位：
MONTANA STATE UNIVERSITY - BOZEMAN
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-15 至 2023-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10372929
关键词：
Address Adoption Affordable Care Act Aging Algorithmic Software Algorithms Benign Biopsy Caliber Cancer Center Categories Cellular Morphology Clinic Clinical Code Collaborations Computer Vision Systems Computer software Current Procedural Terminology Dermatologist Dermatology Dermis Dermoscopy Devices Diagnosis Diagnostic Drops Effectiveness Endoscopes Engineering Epidermis Grant Head and neck structure Image Imaging Techniques Lesion Lesion by Morphology Letters Location Machine Learning Malignant - descriptor Malignant Neoplasms Medicaid services Medicare/Medicaid Memorial Sloan-Kettering Cancer Center Microscope Microscopic Montana Morphology Optics Oral Outcome Pathology Patient Care Patients Performance Predictive Value Procedures Public Health Publishing Research Research Personnel Resolution Sensitivity and Specificity Site Skin Skin Cancer Specificity Surface Technology Testing Time United States Centers for Medicare and Medicaid Services Universities Visual base blind cancer diagnosis clinical examination clinical practice cost design design and construction diagnostic accuracy diagnostic strategy gastrointestinal image guided image processing image registration improved in vivo innovation instrument instrumentation interest lens medical specialties microscopic imaging miniaturize novel novel diagnostics optical imaging prospective test reflectance confocal microscopy response routine practice skin lesion volunteer

项目摘要

1 Dermatologists rely on visual (clinical widefield) and dermoscopic examination of skin lesions to guide the need 2 for biopsy. With this approach, sensitivity is high, but specificity tends to be quite variable and lower, resulting 3 in millions of biopsies of benign lesions every year. To improve specificity, several optical technologies are 4 being developed to noninvasively detect skin cancer. Of these, reflectance confocal microscopy (RCM) is the 5 furthest advanced in clinical utility, proven for diagnosing skin cancers with high sensitivity and specificity. 6 RCM imaging, guided by dermoscopy, detects skin cancers with 2 times superior specificity, and reduces the 7 benign-to-malignant biopsy rate by 2 times, compared to that with dermoscopy alone. In 2016, the Centers for 8 Medicare and Medicaid Services granted current procedural terminology (CPT) reimbursement codes for RCM 9 imaging of skin. RCM imaging combined with dermoscopy is now advancing into clinical practice, sparing pa- 10 tients from unnecessary biopsies of benign lesions. However, toward widespread acceptance and adoption, a 11 key challenge is that clinical widefield examination, dermoscopy and RCM imaging are currently performed as 12 three separate procedures with separate devices. Clinicians do not precisely know the location of RCM imag- 13 es relative to the surrounding contextual lesion morphology that is seen with clinical widefield examination and 14 dermoscopy, resulting in lower and more variable diagnostic accuracy (particularly, sensitivity, positive and 15 negative predictive values). We propose a novel solution: (i) a new objective lens with an integrated micro- 16 camera, to deliver a concurrent widefield image of the skin surface surrounding the location of RCM imaging; 17 (ii) a new software algorithm for widefield image-based tracking of the location of RCM images within a dermoscopic 18 field of view; (iii) a new diagnostic approach that will proactively use widefield imaging to locate RCM images in 19 dermoscopic images. We intend to deliver this integrated widefield clinical, dermoscopic and RCM imaging ap- 20 proach into the clinic, toward a new standard for more accurate, consistent and faster RCM imaging to guide 21 patient care. Preliminary studies with a “mock” objective lens and micro-camera on a bench-top set-up 22 demonstrated excellent optical sectioning (~2 µm) and resolution (~1 µm) for RCM imaging, and accurate and 23 repeatable location of RCM fields-of-view within the widefield image. RCM images showed excellent cellular 24 and morphologic detail in vivo. Our specific aims are (1) to develop a handheld reflectance confocal micro- 25 scope with integrated widefield camera; (2) to develop image processing algorithms for real-time widefield im- 26 aging-guided tracking of RCM image locations within dermoscopic fields; (3) to test and validate performance 27 on 100 patients. Although our proposition is for skin lesions, the research will surely have wider impact for 28 imaging in other settings, particularly, with miniaturized confocal microscopes and endoscopes, which have 29 very small fields-of-view. We are a highly synergistic team from Montana State University, Memorial Sloan 30 Kettering Cancer Center, Northeastern University and Caliber Imaging and Diagnostics (formerly, Lucid Inc.).

1个皮肤科医生依靠视觉（临床广场）和皮肤镜检查皮肤病变来指导需求 2进行活检。通过这种方法，灵敏度很高，但是特异性往往会变化且较低，因此每年数百万个良性病变活检中有3个。为了提高特异性，几种光学技术是 4被开发为非侵入性检测皮肤癌。其中，反射率共聚焦显微镜（RCM）是 5最先进的临床实用性，可证明具有高灵敏度和特异性的诊断皮肤癌。 6 RCM成像以皮肤镜检查为指导，检测到具有优异特异性的2倍的皮肤癌，并降低了皮肤癌与单独的皮肤镜检查相比，7良性到恶性活检率为2倍。 2016年，中心 8 Medicare和Medicaid服务授予RCM的当前程序术语（CPT）报销代码 9皮肤成像。 RCM成像与皮肤镜检查相结合，现在正在临床实践中前进，保留PA- 不必要的良性病变活检中的10个提示。但是，要进行宽度的接受和采用，一个 11关键挑战是临床广场检查，皮肤镜检查和RCM成像目前的执行 12三个单独的程序，带有单独的设备。临床医生并不确切地知道RCM Imag- 13 ES相对于周围的上下文病变形态，该形态在临床广场检查和 14皮肤镜检查，导致诊断准确性较低和更可变（部分，灵敏度，阳性和 15个负预测值）。我们提出了一种新颖的解决方案：（i）具有集成微型的新目标镜头 16相机，以提供RCM成像位置的皮肤表面的同时宽阔图像； 17（ii）一种新的软件算法，用于基于广场图像的跟踪RCM图像的位置。 18视野；（iii）一种新的诊断方法，该方法将主动使用广场成像来定位RCM图像 19个皮肤镜图像。我们打算提供这种综合的广场临床，皮肤镜和RCM成像AP- 20进入诊所，朝着新的标准迈进，以进行更准确，一致和更快的RCM成像来指导 21患者护理。在基准设置上使用“模拟”目标镜头和微型摄像机的初步研究 22展示了出色的光学截面（〜2 µm）和分辨率（〜1 µm），用于RCM成像，准确，并且 23 RCM视野在广场图像中的可重复位置。 RCM图像显示出色的蜂窝 24和体内形态学细节。我们的具体目的是（1）开发手持式反射率共焦微观 - 25范围，具有集成的广场相机；（2）开发实时广场的图像处理算法 - 26衰老引导跟踪RCM图像位置内的皮肤镜磁场中的位置；（3）测试和验证性能 27例100名患者。尽管我们的建议是针对皮肤病变的，但该研究肯定会对 28在其他设置中，特别是具有微型共聚焦显微镜和内窥镜的成像 29个非常小的视野。我们是蒙大拿州立大学纪念斯隆的高度协同团队 30 Kettering Cancer Center，Northeastern University以及口径成像和诊断（以前是Lucid Inc.）。