Development and evaluation of a combined X-ray transmission and diffraction imaging system for pathology

用于病理学的组合 X 射线透射和衍射成像系统的开发和评估

• 批准号: 10699271
• 负责人: Joel Greenberg
• 金额: $ 88.76万
• 依托单位: QUADRIDOX, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-08 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699271
• 关键词: Affect; Algorithmic Software; Area Under Curve; Benchmarking; Breast; Calibration; Carcinoma; Caring; Classification; Clinical; Clinical Pathology; Collaborations; Data; Development; Diagnosis; Diagnostic; Disease; Economics; Equilibrium; Evaluation; Face; Faculty; Goals; Histologic; Hospitals; Hour; Image; Imaging technology; Individual; Insurance; Laboratories; Location; Malignant Neoplasms; Manuals; Marketing; Measurement; Medical; Metadata; Methods; Microscope; Microscopic; Microscopy; Molecular Profiling; Operative Surgical Procedures; Palpation; Pathologist; Pathology; Performance; Phase; Play; Preparation; Process; Productivity; Publishing; Receiver Operating Characteristics; Reproducibility; Research; Resected; Resolution; Roentgen Rays; Role; Sampling; Scanning; Series; Slice; Slide; Small Business Innovation Research Grant; Specimen; Speed; Surface; System; Technology; Testing; Thick; Time; Tissues; Universities; Work; Workload; X ray diffraction analysis; absorption; biobank; cancer site; classification algorithm; clinical diagnosis; clinical imaging; clinical translation; cohort; commercialization; cost; field study; image reconstruction; imaging software; imaging system; improved; malignant breast neoplasm; new technology; pathology imaging; prototype; response; satisfaction; skills; software development; standard of care; tool; transmission process; tumor; usability; user friendly software

ABSTRACT Pathology, which plays a vital role in clinical diagnosis, faces numerous challenges that impact its efficacy. For example, resected specimens often require preparing and analysis of as many as 30-40 slide blocks under a microscope until the disease is confirmed; selection of slices for slide preparation uses subjective methods such as palpation, which depend greatly on the skill of the individual performing the assessment and introduces inconsistency in the clinical process; and for each slide block examined, analysis and annotation requires manual observation of every microscopic region of the tissue. As a result, most pathology evaluations often take 1-3 weeks to analyze samples and reach a conclusion regarding potential cancers. An added challenge is that insurance reimbursements are capped per case regardless of the number of slide blocks processed, with any additional costs being absorbed by the hospital. Consequently, hospitals must balance the trade-off between minimizing the number of slices (for economic viability) and not compromising diagnostic care. These challenges affect not only clinical pathology but also research involving pathology specimens and tissue selection for biobanking. There is a critical need to eliminate subjectivity, reduce pathologists’ workload, and increase throughput in histological analysis. We propose to meet this need by developing a new technology called X-ray diffraction imaging (XRDI), which can scan any number of surgically resected, sliced pathology specimens and automatically indicate the likelihood and location of disease in each slice within minutes. In collaboration with Duke University, we previously built a research prototype XRDI system and demonstrated its utility by scanning and evaluating 300 breast cancer slices with high accuracy and resolution. In this direct-to-phase-II SBIR application, we will now construct a new clinical version of the XRDI scanner that is affordable, reliable, and accurate, and can be directly integrated into the clinical pathology workflow. We will build the scanner, test and evaluate its performance, and demonstrate its utility through field-testing in collaboration with clinical pathology laboratories in the US. This project will provide a first-of-its-kind, commercially feasible XRDI scanner for rapid, non-destructive imaging of pathology specimens with the ability to inform pathologists about the presence and location of cancer within the different tissue slices. The proposed clinical scanner will enable: 1) analysis of the whole slice volume of the specimen rather than a few microns at the surface of a subset of the slices, which is the current standard of care process using microscopy, 2) quantitative identification of disease based on XRD information obtained directly from the tissue, and 3) slice selection based on quantitative, reproducible measurements, thereby eliminating user-related subjectivity. Importantly, it would significantly speed up pathology workflow, providing decisions within hours instead of days, and improve the productivity and profitability of pathology labs by reducing the number of slide blocks analyzed per case.

抽象的 病理学在临床诊断中发挥着至关重要的作用，面临着影响其疗效的众多挑战。 例如，切除的标本通常需要在一个实验室中准备和分析多达 30-40 个滑块。 显微镜检查直至确认疾病；使用主观方法选择切片进行载玻片制备； 作为触诊，这在很大程度上取决于执行评估的个人的技能并引入 临床过程中的不一致；并且对于每个检查的滑块，分析和注释需要手动 观察组织的每个微观区域因此，大多数病理学评估通常需要 1-3 次。 分析样本并得出有关潜在癌症的结论的另一个挑战是。 无论滑块数量多少，每个案例的保险报销都有上限，任何 额外的费用由医院承担，医院必须在两者之间进行权衡。 最大限度地减少切片数量（为了经济可行性）并且不影响诊断护理这些挑战。 不仅影响临床病理学，还影响涉及病理标本和组织选择的研究 迫切需要消除受试者、减少病理学家的工作量并增加 我们建议通过开发一种称为 X 射线的新技术来满足这一需求。 衍射成像（XRDI），可以扫描任意数量的手术切除、切片的病理标本和 在几分钟内自动指示每个切片中疾病的可能性和位置。 杜克大学，我们之前构建了一个研究原型 XRDI 系统，并通过扫描展示了其实用性 并在这个直接进入 II 期的 SBIR 中以高精度和分辨率评估 300 个乳腺癌切片。 应用程序，我们现在将构建新的临床版本 XRDI 扫描仪，该扫描仪价格实惠、可靠且 准确，并且可以直接集成到临床病理工作流程中。我们将构建扫描仪、测试和分析。 评估其性能，并通过与临床病理学合作的现场测试证明其实用性 该项目将提供首创的、商业上可行的 XRDI 扫描仪，用于快速、 病理标本的无损成像，能够告知病理学家其存在和情况 所提出的临床扫描仪将能够：1）分析癌症在不同组织切片中的位置。 样本的整个切片体积，而不是切片子集表面的几微米，即 当前使用显微镜的护理流程标准，2) 基于 XRD 的疾病定量鉴定 直接从组织获得的信息，以及3）基于定量、可重复的切片选择 测量，从而消除与用户相关的主观性，重要的是，它将显着加快速度。 病理工作流程，在数小时而不是数天内提供决策，并提高生产力和 通过减少每个病例分析的滑块数量来提高病理实验室的盈利能力。