Noninvasive prediction of skin precancer severity using in vivo cellular imaging and deep learning algorithms.

非黑色素瘤皮肤癌(NMSC)是人类最常见的癌症 每年导致的死亡人数是黑色素瘤的两倍。一种诊断和诊断的方法 治疗NMSCs需要皮肤活检，并对其进行处理和染色，以进行标准分析 光学显微镜。这个过程对患者来说是痛苦的，活组织检查的侵入性 在NMSC检测中引入延迟，这会导致患者发病率并增加 给医疗系统带来了巨大的成本。EnSpectrum Health的使命是将数字肿瘤学 诊断到早期癌症检测的护理点，其中医疗保健成本和 患者的负担微乎其微。癌症是一种固有的细胞功能障碍，但又是现代的 医学仍然缺乏在不进行活组织检查的情况下观察细胞组织学的基本能力。这种广为流传 临床需求是EnSpectrum及其创新的核心动力。EnSpectrum旨在解决 这种尚未得到满足的临床需求需要一种更好的方法来更早地检测到NMSCs。这将直接连接到第二阶段 申请以已批出的第一期、第二期和第二期B期工程的进度为基础 (R43CA221591、R44CA221591)。在这些项目中，EnSpectrum从概念上取得了进步， 通过技术可行性，并进入临床试验，最近完成了一项关键的 向FDA提交510(K)批准的试验(ClinicalTrials.gov：NCT05619471)。 EnSpectrum创造了第一台便携式、光纤耦合、组合式多光子显微镜 (MPM)和反射共聚焦显微镜(RCM)系统用于NMSC的活体成像。在这 针对第二阶段的提议，EnSpectrum旨在利用其多模式数据的分析能力 并将其扩展到光化性角化病(AK)，这是一种可以进展到NMSC的癌前病变。 EnSpectrum将在AKS患者身上建立一个大规模的组织病理学数字数据库 局部治疗。对治疗无效的AK更有可能进展为NMSC，并且 临床上风险较高。使用治疗结果作为AK严重程度的指标，EnSpectrum将 训练深度学习算法以预测哪些AK仅在病理上无反应 我们的非侵入性图像中的特征。能够在问题AK成为 恶性应加强对高危患者的监测，加快NMSC的检测，以及 减轻低风险患者的手术干预负担。

Nonmelanoma skin cancer (NMSC) represents the most common form of cancer in the human body and causes twice as many fatalities each year as melanoma. 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’s mission is to bring digital oncology diagnostics to the point-of-care for earlier cancer detection where the healthcare cost and burden to patients is minimal. Cancer is an inherently cellular disfunction, and yet modern medicine still lacks the basic ability to view cellular histology without biopsy. This widespread clinical need is the core motivation for Enspectra and its innovations. Enspectra aims to address this unmet clinical need for a better method to detect NMSCs earlier. This direct to Phase II application builds on the progress of awarded Phase I, Phase II, and Phase IIB projects (R43CA221591, R44CA221591). In these projects, Enspectra has progressed from concept, through technical feasibility, and into clinical trials, recently completing enrollment in a pivotal trial for submission to the FDA for 510(k) approval (ClinicalTrials.gov: NCT05619471). Enspectra has created the first portable, fiber coupled, combined multiphoton microscopy (MPM) and reflectance confocal microscopy (RCM) system for in vivo imaging of NMSC. In this direct to Phase II proposal, Enspectra aims to leverage the analytic power of its multimodal data and extend its reach to Actinic Keratosis (AK), a precancerous lesion that can progress to NMSC. Enspectra will build a large-scale digital database of histopathology in AKs on patients before topical therapy. AKs that do not respond to therapy are more likely to progress to NMSC and are clinically of higher risk. Using the therapy outcome as an indicator of AK severity, Enspectra will train a deep learning algorithm to predict which AKs would be unresponsive solely on pathologic features in our noninvasive images. The ability to identify problematic AKs before they become malignant should improve surveillance of high-risk patients, hasten detection of NMSC, and lessen the burden of surgical intervention to low-risk patients.