CoreView and FIBI for rapid-onsite evaluation and molecular profiling of core-needle breast biopsies.

CoreView 和 FIBI 用于对核针乳腺活检进行快速现场评估和分子分析。

• 批准号: 10613211
• 负责人: RICHARD M. LEVENSON
• 金额: $ 32.9万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10613211
• 关键词: Address; Antibodies; Antigen Targeting; Area; Artificial Intelligence; Biological Assay; Biopsy; Breast; Breast Cancer Patient; Breast biopsy; Caring; Chemistry; Classification; Clinic; Clinic Visits; Clinical; Collection; Computer Assisted; Consumption; Core Biopsy; Coupled; Development; Devices; Diagnosis; Diagnostic; Diagnostic Imaging; Disease; ERBB2 gene; Ensure; Evaluation; Fluorescence; Formalin; Goals; Hand; Histology; Histopathology; Human; Human Resources; Image; Immunohistochemistry; Immunophenotyping; Institutional Review Boards; Label; Laboratories; Ligands; Mammary Gland Parenchyma; Mass in breast; Mechanics; Molecular; Molecular Profiling; Nature; Needle biopsy procedure; Needles; Nucleic Acids; Optics; Paraffin Embedding; Pathologist; Pathology; Patient Triage; Patients; Peptides; Periodicity; Phenotype; Preparation; Procedures; Process; Rapid diagnostics; Reagent; Reproducibility; Research; Resolution; Resource-limited setting; Resources; Sampling; Site; Slide; Specimen; Specimen Handling; Stains; Stream; System; Technology; Testing; Time; Tissues; Training; Travel; Triage; Validation; Vial device; breast lesion; cloud based; digital; digital imaging; imaging software; improved; instrument; multiplexed imaging; point of care; preservation; rapid technique; rapid test; sample fixation; sensor; skills; tool; treatment planning; treatment site; validation studies; virtual

Abstract Patients with concerning breast masses require diagnosis, triage, and management. This proposal seeks to combine three recently developed technologies to provide rapid diagnostic support for patient breast tumor evaluation. Currently, this process consists of biopsy, standard histology, phenotype determination via im- munohistochemistry, and increasingly, molecular assays. In well-served areas, the challenges involve obtain- ing appropriate and representative biopsies, waiting for slide preparation, review by a pathologist, then im- munostaining (IHC), and optionally, submission for nucleic-acid based studies. We propose a simple tissue-direct-to-digital slide-free imaging solution (FIBI, fluorescence imitating brightfield imaging, UC Davis) coupled with a virtually hands-off millifluidic specimen handling device (CoreView, UW). Images, intrinsically digital, are of diagnostic quality, and can be interpreted locally by trained pathology per- sonnel, or streamed anywhere in the world for real-time evaluation. Eventually, on-site or cloud-based com- puter-assisted tools will be available. An additional goal is to achieve same-session multiplexed immunostain- ing and imaging, based on rapid-quench click chemistry approaches developed by Dr. Ko (Univ. Penn.) We will build and test versions of the combined imaging and automated sample handling of needle-derived specimens initially using excess fresh or recently fixed human breast tissue, and subsequently clinically ac- quired core-needle biopsies. Tasks involve optimization of staining, imaging, image display, reproducibility demonstration, and sample integrity assessments. Incorporation of single-step immunostaining with far-red la- bels will be included, and methods for rapid probe cycling (for multiplexing—ER, PR, HER2) will be applied and tested. Subspecialty pathology review will ensure that the FIBI images and immunostains are reliable and of diagnostic quality. The goal is to implement a context-appropriate, automated instrument that can capture his- topathology images from core-needle biopsies, while retaining their integrity for downstream processing as needed. Results will be available within minutes and allow for informed patient triage or even immediate on-site treatment, especially valuable if the patient has had to travel long distances to reach the clinic. Statement of Potential Impact: Current biopsy evaluation interposes at least 1-3 days delay, and involves consuming some or all of small tissue specimens. Immunostaining contributes additional delay. The situation is more challenging in poorly served areas, as histology laboratories and the pathologists capable of interpreting the results are rare outside major urban centers. The CoreView-FIBI approach could dramatically improve pa- tient-level care velocity, but also enterprise-level efficiency, allowing for same-day disease treatment planning. For biospecimen applications, preanalytical variables will be under complete control, the non-destructive nature of the imaging means that more tissue is available for storage and research, and imaging of the specimen prior to banking provide assurance of tissue content and abundance estimates of relevant components.

抽象的 与乳腺肿块有关的患者需要诊断，分类和管理。该提议试图 结合了最近开发的三项技术，为患者乳腺肿瘤提供快速诊断支持 评估。目前，此过程包括活检，标准组织学，表型通过IM-确定 muno组织化学以及越来越多的分子测定法。在服务良好的地区，挑战涉及获得 - 进行适当且具有代表性的活检，等待幻灯片准备，审查病理学家，然后进行 MunoSting（IHC），并且可选地提交基于核酸的研究。 我们提出了一个简单的组织直接到数字的无幻灯片成像溶液（纤维，模仿Brightfield的荧光 成像，加州大学戴维斯（UC Davis），再加上实际上是手持毫米的标本处理设备（Coreview，UW）。 图像本质上是数字质量的，可以通过训练有素的病理学来解释 Sonnel，或播放世界上任何地方进行实时评估。最终，现场或基于云的com- 将提供推杆辅助工具。另一个目标是实现相同的多重免疫接种剂 - 基于Ko博士（Univ。Penn。）开发的快速点击化学方法的ING和成像。 我们将构建和测试针形的组合成像和自动化样品处理的针头处理的版本 标本最初使用过量的新鲜或最近固定的人类乳腺组织，然后在临床上进行 必需的核心细节活检。任务涉及优化染色，成像，图像显示，可重复性 演示和样本完整性评估。将单步免疫染色与远红色的LA-合并 将包括BEL，并将应用快速探针循环的方法（用于多重型 - ER，PR，HER2），并将应用于 测试。亚科病理审查将确保纤维图像和免疫抑制品可靠，并且 诊断质量。目的是实施一个适合上下文的自动化工具，可以捕获His-- 来自核心针头活检的拓扑图像，同时保留其完整性以进行下游处理 需要。结果将在几分钟之内提供，并允许有知情的患者分类，甚至可以立即进行现场现场 治疗，如果患者不得不长距离到达诊所，则特别有价值。 潜在影响的说明：当前的活检评估插入至少1-3天延迟，涉及 消耗一些或全部的小组织标本。免疫染色会造成额外的延迟。情况是 作为组织学实验室和能够解释的病理学家，服务不善的领域挑战 结果在主要城市中心以外很少见。 CoreView-Fibi方法可以极大地改善PA- Tient级护理速度，但也可以进行企业水平的效率，从而允许当天的疾病治疗计划。 对于生物循环应用，将完全控制放分析变量，无损性质 成像意味着更多的组织可用于存储和研究，以及先验的样品成像 银行业务可保证组织含量和相关组件的抽象估计。