Practical high resolution microscopy of un-cut, un-embedded lung biopsies

未切割、未包埋肺活检的实用高分辨率显微镜

• 批准号: 9408066
• 负责人: Michael John Levene
• 金额: $ 109.13万
• 依托单位: APPLIKATE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-02 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9408066
• 关键词: Adoption; Ancillary Study; Biopsy; Biopsy Specimen; Caring; Client; Clinical; Clinical Research; Computer software; Consultations; Core Biopsy; DNA; Data; Development; Devices; Diagnosis; Diagnostic; Distress; Elements; Environment; Error Sources; Evaluation; Failure; Feedback; Funding; Growth; Histologic; Histology; Hospital Sizes; Hospitals; Hour; Image; Image Analysis; Imagery; Laboratory Personnel; Liquid substance; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Manuals; Methodology; Methods; Microscope; Microscopy; Molecular; Molecular Analysis; Molecular Target; Morphologic artifacts; Organ; Pathologist; Pathology; Patient risk; Patients; Pattern; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Preparation; Price; Procedures; Process; Protocols documentation; Reagent; Research; Resolution; Running; Sample Size; Sampling; Services; Site; Slide; Small Business Innovation Research Grant; Solid; Specimen; Speed; Staining method; Stains; System; Systems Development; Technology; Testing; Time; Tissue imaging; Tissues; Training; Update; Vertebral column; Visual; Work; base; cancer diagnosis; cost; design; design and construction; diagnostic accuracy; digital; imaging approach; improved; instrumentation; novel; novel strategies; personalized medicine; pressure; prototype; success; tertiary care; tissue processing; trend; virtual

Project Summary and Relevance The aim of this Phase II SBIR proposal from Applikate Technologies, LLC, is to build on the successful completion of our Phase I milestones with the design, construction, and testing of prototype devices and software for implementing the ClearView tissue histology system in clinical settings by laboratory personnel. ClearView is a novel approach to performing complete and non-destructive imaging of tissue specimens for lung and other cancers. Lung cancer biopsy diagnosis error rates may run as high as 15%. Although there are many potential sources of error, important aspects relate to limitations of current methods for tissue processing and analysis. Standard methods limit the amount of tissue that can be visualized by the diagnostic pathologist and that is available for personalized-medicine testing. They also are not amenable to consultation with off-site experts and are dependent on manual processing by adequately trained histotechnologists. Applikate Technologies has developed ClearView, a complete, non-destructive, fast, tissue processing and imaging approach to histology that improves on limits of slide-based histology by providing complete tissue visualization, reducing artifacts of preparation, permitting improved quantitative interpretation, showing additional growth pattern information, and eliminating extensive manual preparation. The ClearView system yields images that are, in many cases, superior even to traditionally processed histology slides with pseudo-coloring that is virtually indistinguishable from conventional staining, all in an entirely digital format ready for remote access and storage. And ClearView is fast enough to provide diagnostic quality images in under two hours for same day diagnosis. We have also demonstrated, during our Phase I funding, that the ClearView process yields orders of magnitude more DNA for molecular analyses and is compatible with immunohistochemical staining. Furthermore, the methodology is applicable not only to lung cancer diagnosis, but to evaluation of practically any solid tissue cancer. The specific aims of the proposal are to: 1) Develop an application-specific, high-speed multiphoton microscope and associated software; 2) Develop the ClearView prototype tissue chamber, and 3) Develop the ClearView prototype tissue processor. These three elements, along with proprietary reagents, form the core of the ClearView system. Following in-house testing, two complete prototype systems will be placed in two hospitals, one a large tertiary care center and the second a mid-sized hospital, for on-site testing and feedback by non-expert users in a clinical setting. Successful completion of these aims will set the stage for a Phase III transition to regulatory approval and provide a proven platform for early implementation through service work for academic research and clinical research groups.

项目摘要和相关性 Applikate Technologies, LLC 提出的第二阶段 SBIR 提案的目的是在成功的基础上再接再厉 通过原型设备的设计、构建和测试完成第一阶段里程碑 用于由实验室人员在临床环境中实施 ClearView 组织组织学系统的软件。 ClearView 是一种对组织样本进行完整、无损成像的新颖方法 肺癌和其他癌症。 肺癌活检诊断错误率可能高达 15%。虽然有很多潜力 误差来源，重要方面与当前组织处理和分析方法的局限性有关。 标准方法限制了诊断病理学家可以可视化的组织数量，即 可用于个性化医疗测试。他们也不愿意咨询场外专家 并且依赖于经过充分培训的组织技术人员的手工处理。应用技术 开发了 ClearView，一种完整的、非破坏性的、快速的组织处理和成像方法 组织学通过提供完整的组织可视化来改进基于载玻片的组织学的限制，减少 制备伪影，允许改进定量解释，显示额外的生长模式 信息，并消除大量的手动准备。 ClearView 系统生成的图像是 在许多情况下，甚至优于传统处理的组织学载玻片，其伪着色实际上是 与传统染色没有区别，全部采用完全数字格式，可供远程访问和 贮存。 ClearView 的速度足够快，可以在同一天的两个小时内提供诊断质量的图像 诊断。在第一阶段融资期间，我们还证明了 ClearView 流程产生的订单 用于分子分析的更多 DNA，并且与免疫组织化学染色兼容。 此外，该方法不仅适用于肺癌诊断，还适用于实际评估 任何实体组织癌症。 该提案的具体目标是： 1）开发专用的高速多光子 显微镜及相关软件； 2) 开发 ClearView 原型组织室，以及 3) 开发 ClearView 原型组织处理器。这三个要素与专有试剂一起构成了核心 ClearView 系统。经过内部测试后，两个完整的原型系统将被放置在两个 医院，一是大型三级医疗中心，二是中型医院，用于现场测试和反馈 由非专家用户在临床环境中使用。这些目标的成功完成将为第三阶段奠定基础 过渡到监管审批，并通过服务工作为早期实施提供经过验证的平台 适用于学术研究和临床研究团体。