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

 描述(由申请人提供)：Applikate Technologies，LLC的这项第一阶段SBIR提案的目标是验证和优化RapidView，这是一种术中切除组织的显微分析的新方法。目前，病理学家分析快速冷冻组织切片，为美国每年约300万次手术的外科切除提供即时的组织学评估。由此给外科医生的反馈通常包括对切除的肿瘤边缘的评估，结果导致约40%的病例改变了手术过程。术中冰冻切片的使用已被证明可以降低再次手术率，以及与其相关的风险和患者的压力，并降低提供者和保险公司的总成本。然而，来自冷冻过程的文物和困难 冷冻某些组织类型限制了冷冻切片的使用，并可能导致严重错误。这个 由此导致的形态扭曲，再加上在患者仍在手术期间提供反馈的严重时间压力，使术中冰冻组织分析成为病理学家执行的最困难的任务之一。RapidView通过在与冰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使用新鲜的、未冷冻的组织，因此避免了切割和冻结人工制品。与冰冻切片相比，RapidView的处理技术要求也较低，预计适用于所有组织类型。除了改变 在进行术中组织评估的方式上，RapidView可以改变非术中病理的正常工作流程，在20分钟内提供足以进行初步诊断的图像，而传统方法使用蜡包埋组织块需要数天时间。这项建议的具体目的是为实际实施优化RapidView组织处理协议，并确认与组织存储和支持性测试的兼容性，这些测试有时会在快速分析后使用。这项提议的目标的成功完成将验证RapidView作为冷冻切片的卓越替代品和蜡包埋的潜在替代品，为在临床环境中实施RapidView的专用硬件的第二阶段开发奠定基础。

 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.