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.

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