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

具有颜色对比的亚细胞结构无创多光子成像可快速检测皮肤癌

• 批准号: 10250264
• 负责人: Gabriel Nestor Sanchez
• 金额: $ 196.85万
• 依托单位: ENSPECTRA HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-25 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10250264
• 关键词: Address; Adoption; Advanced Development; Area; Award; Basal cell carcinoma; Benign; Biopsy; Blinded; Cancer Detection; Cancer Etiology; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Color; Conduct Clinical Trials; Coupled; Data; Defect; Dermatologist; Development; Devices; Diagnosis; Documentation; Early Diagnosis; Engineering; Ensure; Epithelial; Evaluation; Eye; Fiber; Future; Goals; Gold; Government; Grant; Health; Healthcare Systems; Histology; Histopathology; Hour; Human; Human body; Image; Image Analysis; Imaging Device; Incidence; Insurance; Lasers; Left; Lesion; Libraries; Light; Literature; Malignant Neoplasms; Medical Societies; Medicine; Methods; Microscope; Microscopy; Miniaturization; Modification; Morbidity - disease rate; Operative Surgical Procedures; Optics; Pain; Pathologic; Pathologist; Pathology; Patients; Performance; Phase; Physicians; Physiologic pulse; Privatization; Process; Readiness; Research; Resolution; Scanning; Secure; Silicon; Site; Skin; Skin Cancer; Skin Carcinoma; Slide; Specificity; Speed; Stains; Subcellular Anatomy; Subcellular structure; Surgeon; System; Technology; Testing; Time; Tissues; United States Food and Drug Administration; base; care providers; cellular imaging; clinical practice; cohort; commercialization; cost; data acquisition; design; diagnostic accuracy; experience; human subject; image processing; imaging system; improved; in vivo; in vivo imaging system; innovation; manufacturability; microscopic imaging; multiphoton imaging; multiphoton microscopy; non-invasive imaging; novel strategies; performance tests; photomultiplier; point of care; portability; prospective; rapid detection; sensitivity training; skin disorder; software development; stem; targeted imaging; usability; verification and validation

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).

非黑色素瘤皮肤癌 (NMSC) 是人类最常见的癌症形式 身体。诊断和治疗 NMSC 的方法需要经过处理的皮肤活检 并染色以在标准光学显微镜上进行分析。这个过程对于患者来说是痛苦的 活检的侵入性导致 NMSC 检测出现延迟，这有助于 患者发病率并增加医疗保健系统的大量成本。 EnSpectra 健康公司 （Enspectra）旨在解决对更好的 NMSC 检测方法的未满足的临床需求 早些时候。该 IIB 期申请建立在已获得的 I 期和 II 期项目进展的基础上 项目（NCI，2R44CA221591-02A1）。在这笔资助的第一阶段，EnSpectra 展示了 开发了用于人体临床研究的便携式皮肤成像显微镜（目标 1）的可行性 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) 的人类受试者中证明了检测 BCC 的病理特征（目标 3）。 EnSpectra 创造了第一个光纤耦合多光子 用于皮肤细胞解剖学体内成像的显微镜 (MPM) 系统。在本次资助的第二阶段， EnSpectra 推进了便携式皮肤成像显微镜的开发（目标 1）， 开发了目标皮肤疾病的幻灯片图像库，将 MPM 与传统方法进行比较 组织学（目标 2），并有望提前完成体内人体性能测试（目标 3） 到第二阶段结束日期。第二阶段目标的完成将使 EnSpectra 能够建设 支持向美国食品药品监督管理局提交 510(k) 的临床证据 管理（FDA）许可。在此阶段 IIB 提案中，EnSpectra 将完成两个目标 目标：目标 1) 开发和制造 8 台商用便携式皮肤成像显微镜 准备（12 个月），目标 2）进行临床试验以支持报销文献 （24 个月）。