Rapid Needle Biopsy Assessment at Point of Care to advance personalized cancer therapy

护理点快速针活检评估以推进个性化癌症治疗

• 批准号: 9886701
• 负责人: Eric J Seibel
• 金额: $ 29.75万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9886701
• 关键词: Automation; Biological Markers; Biopsy; Breast; California; Carcinoma; Characteristics; Classification; Clinical; Computers; Core Biopsy; Data Analyses; Dehydration; Development; Devices; Diagnosis; Epidermal Growth Factor; Estrogen Receptors; Evaluation; Feasibility Studies; Feedback; Fluorescence; Formalin; Fresh Tissue; Future; Genomics; Goals; Guidelines; Histopathology; Human; Image; Immunophenotyping; Individual; Intervention; Legal patent; Lesion; Liquid substance; Lung; Malignant Neoplasms; Manuals; Measures; Methods; Microdissection; Microscopy; Microtomy; Molecular; Molecular Probes; Morphology; Multiomic Data; Needle biopsy procedure; Needles; Pancreas; Paraffin Embedding; Pathology; Phenotype; Precision therapeutics; Preparation; Procedures; Process; Progesterone Receptors; Proteomics; Pump; RNA; Sampling; Series; Shapes; Specimen; Speed; Stains; Standardization; Structure; Surface; System; Technology; Testing; Therapeutic; Time; Tissue Preservation; Tissue Procurements; Tissue Sample; Tissue Stains; Tissue Viability; Tissues; Triage; Tube; Universities; Validation; Washington; Work; base; breast cancer diagnosis; cancer biomarkers; cancer cell; cancer subtypes; cancer therapy; computerized; design; epigenomics; fluorescence imaging; image processing; instrumentation; malignant breast neoplasm; metabolomics; minimally invasive; molecular marker; multimodality; novel; personalized cancer therapy; personalized medicine; point of care; preservation; prevent; processing speed; protein expression; prototype; radiologist; response; robot control; sample fixation; tissue trauma; transcriptomics; treatment planning; tumor; ultraviolet; virtual

Project Summary Currently there are no standard guidelines followed for core needle biopsy (CNB) acquisition and preparation. Millions of CNBs are procured annually as the preferred minimally invasive procedure for diagnosing breast cancer and assessing therapeutic strategies based on biomarkers from these small biospecimens. However, the downstream steps in pathology were originally not designed for CNBs – a series of manual procedures that are not standardized. These are: adequacy testing, fixation & dehydration, paraffin embedding, thin-sectioning, staining for image-based morphological analysis, immuno-histochemical (IHC) analysis, and subsequent microdissection to enrich for RNA extraction. Our project is designed to rapidly evaluate the CNB for adequacy, the presence of cancer cells to make a diagnosis, using CoreView millifluidic device from the University of Washington, Seattle. Automated computer-controlled fluidic pumps help to remove the CNB from the needle, transport, clean and stain the tissue surface in a repeatable system designed for CNBs. In partnership with the University of California at Davis, the new method of microscopy with ultraviolet surface excitation will be used which rapidly produces images appear to match the standard H&E images used for adequacy testing. In addition, MUSE will be expanded to include multiplexed molecular of the same CNB. High clinical impact for personalized medicine is provided by this multiplexed fluorescence immunostaining of the biopsy to determine ER/PR and HER2 expression levels that are co-registered with the virtual H&E. The entire process of multiplexed MUSE imaging at the point of care allows the specimen to remain unfixed during this process, which triages one of the CNBs into genomic and other ‘omics analyses in the future that require high yield and quality of biomarkers. The other 1 or 2 CNBs can continue into formalin fixed paraffin embedded conventional histopathology work flow for the future validation of this rapid assessment system. In this feasibility study, the first molecular and morphological CNB instrumentation will be designed and fabricated based on CoreView-MUSE patented technologies. Testing will compare the CNB surface images compared to conventional thin section H&E and IHC as well as the quality and quantity of RNA from these two approaches. Pilot testing of full automation will determine the ultimate speed of processing from needle to multimodal adequacy determination that should range from 5 to 15 minutes at the point of care. Once developed and validated for breast cancer, the CoreView-MUSE system will be expanded to lung, pancreas, and other cancers that rely on CNB accurately sampling cancer from the lesion and providing phenotype classifications for precision therapies.

项目摘要 目前尚未遵循核心针头活检（CNB）的标准准则和 准备。每年采购数百万个CNB作为首选的最低侵入性程序 根据这些小的生物标志物诊断乳腺癌并评估治疗策略 生物测量。但是，病理学的下游步骤最初不是为CNB设计的 一系列未标准化的手动程序。这些是：充足性测试，固定和 脱水，石蜡嵌入，薄切，染色，用于基于图像的形态分析， 免疫 - 历史化学（IHC）分析和随后的显微解剖，以富集RNA提取。 我们的项目旨在迅速评估CNB以获得适当性，即癌细胞的存在以使 诊断，使用西雅图华盛顿大学的CoreView Millifluidic设备。自动化 计算机控制的流体泵有助于从针头，运输，清洁和不锈钢中删除CNB 为CNB设计的可重复系统中的组织表面。与大学合作 加利福尼亚在戴维斯（Davis），将使用具有紫外线表面兴奋的新的显微镜方法 迅速产生的图像似乎与用于充分测试的标准H＆E图像相匹配。在 此外，缪斯将扩展到包括同一CNB的多重分子。高临床 这种多重荧光免疫染色提供了对个性化医学的影响 活检以确定与虚拟H＆E共同注册的ER/PR和HER2表达水平。这 在护理点上的多重缪斯成像的整个过程允许样品保持不变 在此过程中，将未来的一个CNB分类为基因组和其他“ OMICS”分析 这需要高产和质量生物标志物。其他1或2个CNB可以继续进入福尔马林 固定的石蜡嵌入了常规组织病理学工作流动，以便将来验证这一快速的验证 评估系统。在这项可行性研究中，第一分子和形态学CNB仪器 将根据CoreView-Muse专利技术设计和制造。测试将进行比较 与传统的薄段H＆E和IHC相比，CNB表面图像以及质量和质量和 这两种方法的RNA数量。完全自动化的试点测试将确定 从针到多模式充足性确定的最终处理速度应范围 护理点的5到15分钟。一旦开发和验证了乳腺癌， CoreView-Muse系统将扩展到肺部，胰腺和其他依赖CNB的癌症 准确地从病变中抽样癌症并提供表型分类以确保精确 疗法。