A new approach to fast, diagnostic-quality, intraoperative microscopic examination

一种快速、诊断质量的术中显微镜检查的新方法

• 批准号: 8981239
• 负责人: Michael John Levene
• 金额: $ 21.67万
• 依托单位: APPLIKATE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-15 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8981239
• 关键词: Address; Adipose tissue; Breast; Cells; Clinical; Core Biopsy; Development; Diagnosis; Diagnostic; Dyes; Equilibrium; Evaluation; Excision; Exclusion; Feedback; Follow-Up Studies; Freezing; Frozen Sections; Funding; Goals; Graft Rejection; Hematoxylin and Eosin Staining Method; Histocompatibility Testing; Image; Imaging Techniques; Insurance Carriers; Lead; Microscope; Microscopic; Morbidity - disease rate; Morphologic artifacts; Morphology; Operative Surgical Procedures; Optics; Outcome; Pathologist; Pathology; Patients; Phase; Process; Protocols documentation; Provider; Repeat Surgery; Request for Proposals; Risk; Sampling; Slice; Small Business Innovation Research Grant; Soft Tissue Neoplasms; Solutions; Specimen; Speed; Staging; Staining method; Stains; Stress; Surface; Surgeon; System; Techniques; Technology; Testing; Time; Tissue Embedding; Tissue Fixation; Tissue Preservation; Tissue Sample; Tissues; United States; Waxes; Work; cost; improved; intraoperative imaging; novel; novel strategies; operation; pressure; process optimization; public health relevance; sample fixation; tissue processing; tumor

 DESCRIPTION (provided by applicant): The goal of this Phase I SBIR proposal from Applikate Technologies, LLC, is to validate and optimize RapidView, a novel approach to intraoperative microscopic analysis of excised tissue. Currently, pathologists analyze flash frozen tissue sections to provide immediate histological evaluation of surgical excisions for ~3 million operations per year in the United States. The resulting feedback to the surgeon, which often includes assessment of excised tumor margins, results in alterations to the course of surgery in ~40% of cases. Use of intraoperative frozen sections has been shown to reduce rates of re-operation, with its associated risks and stress for the patient, and decrease total costs to both the provider and insurer. However, artifacts from the freezing process and difficulty freezing certain tissue types limit the use of frozen sections and can lead to critical errors. The resulting distortions in morphology, combined with severe time pressure to provide feedback while the patient is still in surgery, make intraoperative frozen tissue analysis one of the most difficult tasks a pathologist performs. RapidView addresses these problems by providing image quality on par with or better than permanent hematoxylin and eosin stained sections in the same time frame as frozen sections. RapidView uses fresh, unfrozen tissue and thereby avoids cutting and freezing artifacts. The processing for RapidView is also less technically demanding than that of frozen sections and is expected to work with all tissue types. In addition to changing the way intraoperative tissue evaluation is performed, RapidView could change the normal workflow of non-intraoperative pathology by providing images sufficient for primary diagnosis in < 20 minutes, compared with days for conventional approaches that use wax embedded tissue blocks. The specific aims of this proposal are to optimize the RapidView tissue processing protocol for practical implementation and to confirm compatibility with tissue storage and supportive tests sometimes employed following rapid analysis. Successful completion of the aims of this proposal will validate RapidView as a superior alternative to frozen sections and as a potential replacement for wax embedding, setting the stage for Phase II development of specialized hardware for implementing RapidView in a clinical setting.

 描述（由申请人提供）：来自Escherkate Technologies，LLC的该I期SBIR提案的目标是验证和优化RapidView，这是一种对切除组织进行术中显微镜分析的新方法。目前，病理学家分析快速冷冻组织切片，为美国每年约300万例手术的手术切除提供即时组织学评价。由此产生的反馈给外科医生，其中往往包括评估切除的肿瘤边缘，导致手术过程中的约40%的情况下的改变。术中冷冻切片的使用已被证明可以降低再次手术的发生率，降低患者的相关风险和压力，并降低提供者和保险公司的总成本。但是，文物从冷冻过程和难度 冷冻某些组织类型限制了冷冻切片的使用，并可能导致严重的错误。的 所导致的形态学上的变形，以及在患者仍在手术中时提供反馈的严重时间压力，使得术中冷冻组织分析成为病理学家执行的最困难的任务之一。RapidView通过在与冷冻切片相同的时间范围内提供与永久性苏木精和伊红染色切片相同或更好的图像质量来解决这些问题。RapidView使用新鲜、未冷冻的组织，从而避免切割和冷冻伪影。RapidView的处理技术要求也低于冷冻切片，预计可用于所有组织类型。除了改变 RapidView可以改变非术中病理学的正常工作流程，在20分钟内提供足够的图像进行初步诊断，而使用蜡包埋组织块的传统方法需要几天。本提案的具体目的是优化RapidView组织处理方案的实际实施，并确认与组织储存和快速分析后有时采用的支持性测试的兼容性。本提案目标的成功完成将验证RapidView作为冷冻切片的上级替代品和蜡包埋的潜在替代品，为在临床环境中实施RapidView的专用硬件的II期开发奠定基础。