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: 10393060
• 负责人: Gabriel Nestor Sanchez
• 金额: $ 121.28万
• 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/10393060
• 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。这个过程对病人来说是痛苦的， 并且活检的侵入性引入了NMSC检测的延迟，这有助于 患者发病率，并增加了医疗保健系统的大量成本。EnSpectra Health，Inc （Enspectra）旨在解决未满足的临床需求，以获得更好的方法来检测NMSC 之前此IIB期申请基于已授予的第一阶段和第二阶段的进展 项目（NCI，2R44CA221591 - 02A1）。在第一阶段，EnSpectra展示了 便携式皮肤成像显微镜用于人类临床研究的可行性（目标1），开发 用于数据采集、图像处理和改进用户界面的软件（目标2），以及 在5名患有基底细胞癌（BCC）的人类受试者中证实了检测 BCC的病理特征（目的3）。EnSpectra创建了第一个光纤耦合多光子 显微镜（MPM）系统用于皮肤细胞解剖结构的体内成像。在第二阶段的赠款， EnSpectra推进了其便携式皮肤成像显微镜（Aim 1）的开发， 开发了一个目标皮肤疾病的幻灯片图像库，将MPM与传统的 组织学（目标2），并有望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能够建立 支持美国食品药品监督管理局510（k）申报的临床证据 管理局（FDA）批准。在本阶段IIB提案中，EnSpectra将完成两个 目的：1）开发和制造8个便携式皮肤成像显微镜，用于商业 准备就绪（12个月），目标2）开展临床试验，以支持文献报销体系 (24月）。