Noninvasive multiphoton imaging of subcellular structures with color contrast for rapid detection of skin cancers

非黑色素瘤皮肤癌(NMSC)是人类最常见的癌症 尸体。诊断和治疗NMSCs的方法需要进行皮肤活检 并在标准光学显微镜上进行染色分析。这个过程对病人来说是痛苦的， 而活检的侵袭性给NMSC的检测带来了延迟，这有助于 这会降低患者的发病率，并增加医疗保健系统的大量成本。EnSpectra Health，Inc. (EnSpectrum)旨在解决临床上尚未满足的检测NMSCs的更好方法的需求 早些时候。此IIB阶段申请是在已授予的第一阶段和第二阶段进展的基础上进行的 项目(NCI，2R44CA221591-02A1)。在这笔赠款的第一阶段，EnSpectra展示了 便携式皮肤成像显微镜用于人体临床研究的可行性(目标1) 用于数据采集、图像处理和改进的用户界面的软件(目标2)，以及 在5名患有基底细胞癌(BCC)的人类受试者中展示了检测到 基底细胞癌的病理特点(目的3)。EnSpectra创造了第一个光纤耦合多光子 用于皮肤细胞解剖活体成像的显微镜(MPM)系统。在这笔赠款的第二阶段， EnSpectra推动了其便携式皮肤成像显微镜的开发(Aim 1)， 开发了一个针对皮肤病的幻灯片图片库，比较了MPM和传统皮肤病 组织学(目标2)，并有望在之前完成活体人体性能测试(目标3) 至第二阶段结束日期。第二阶段目标的完成将使EnSpectra能够建立 支持美国食品和药物510(K)提交的临床证据 美国食品和药物管理局(FDA)批准。在此阶段IIB提案中，EnSpectra将实现两个目标 目标：目标1)开发和制造8台便携式商业皮肤成像显微镜 准备(12个月)，目标2)进行临床试验以支持报销文献正文 (24个月)。

Nonmelanoma skin cancer (NMSC) represents the most common form of cancer in the human body. The method for diagnosing and treating NMSCs requires a skin biopsy that is processed and stained for analysis on a standard optical microscope. This process is painful for patients, and the invasiveness of biopsy introduces a delay into NMSC detection, which contributes to patient morbidity and adds substantial cost to the healthcare system. EnSpectra Health, Inc (Enspectra) aims to address the unmet clinical need for a better method to detect NMSCs earlier. This Phase IIB application builds on the progress of awarded Phase I and Phase II projects (NCI, 2R44CA221591-02A1). In Phase I of this grant, EnSpectra demonstrated the feasibility of a portable, skin-imaging microscope for human clinical studies (Aim 1), developed software for data acquisition, image processing, and improved user interface (Aim 2), and demonstrated in 5 human subjects with basal cell carcinoma (BCC) the ability to detect pathologic features of BCC (Aim 3). EnSpectra has created the first fiber coupled multiphoton microscopy (MPM) system for in vivo imaging of skin cellular anatomy. In Phase II of this grant, EnSpectra advanced the development of its portable, skin-imaging microscope (Aim 1), developed a library of slide images of targeted skin diseases comparing MPM to traditional histology (Aim 2), and is on track to complete in vivo human performance testing (Aim 3) prior to the Phase II end date. The completion of the Phase II aims will enable EnSpectra to build clinical evidence in to support a 510(k) submission for United States Food & Drug Administration (FDA) clearance. In this Phase IIB proposal EnSpectra will accomplish two aims: Aim 1) Develop and manufacture 8 portable, skin-imaging microscopes for commercial readiness (12 months), Aim 2) Conduct clinical trial to support reimbursement body of literature (24 months).