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。斑马医疗 科技(ZMT)旨在解决尚未满足的临床需求，寻找更好的检测方法 早些时候，NMSCs。在这笔赠款的第一阶段，ZMT展示了一种便携式皮肤-- 人类临床研究成像显微镜(AIM 1)，开发了数据采集软件， 图像处理和改进的用户界面(目标2)，并在5名人体受试者中进行了演示 对于基底细胞癌(BCC)，能够发现基底细胞癌的病理特征(目标3)。ZMT 创造了第一个用于活体成像的光纤耦合多光子显微镜(MPM)系统 皮肤细胞解剖学。在这一成功的基础上，ZMT将在第二阶段至 支持美国食品和药物管理局(FDA)批准的510(K)申请。 这是将这项技术应用于常规临床的必要和有价值的一步。 练习一下。在这项建议中，我们将实现三个目标：目标1)促进 用于临床试验的便携式皮肤成像显微镜，目标2)开发用于临床试验的幻灯片图像库 靶向皮肤病将MPM与传统组织学进行比较，目的3)在体内进行 人体性能测试，以支持FDA批准。

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. Zebra Medical Technologies (ZMT) aims to address the unmet clinical need for a better method to detect NMSCs earlier. In Phase I of this grant, ZMT 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). ZMT has created the first fiber coupled multiphoton microscopy (MPM) system for in vivo imaging of skin cellular anatomy. Building on this success, ZMT will build clinical evidence in Phase II to support a 510(k) submission for United States Food & Drug Administration (FDA) clearance. This is a necessary and valuable step towards bringing this technology into regular clinical practice. In this proposal we will accomplish three aims: Aim 1) Advance development of the portable, skin-imaging microscope for a clinical trial, Aim 2) Develop library of slide images of targeted skin diseases comparing MPM to traditional histology, and Aim 3) Conduct in vivo human performance testing to support FDA clearance.