Breast core-needle diagnostics in LMICs via millifluidics and direct-to-digital imaging: development and validation in Ghana

通过微流体和直接数字成像对中低收入国家进行乳腺空心针诊断：在加纳进行开发和验证

• 批准号: 10416550
• 负责人: RICHARD M. LEVENSON
• 金额: $ 64.19万
• 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: 2023-07-05 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10416550
• 关键词: Address; American; Area; Artificial Intelligence; Back; Breast; Calibration; Caregivers; Caring; Centenarian; Cessation of life; Clinic; Clinical; Clinical Pathology; Collaborations; Computer software; Consultations; Core Biopsy; Costs and Benefits; Country; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic Neoplasm Staging; Disease Management; ERBB2 gene; Engineering; Environment; Evaluation; Evolution; Feedback; Fees; Generations; Ghana; Goals; Hand; Health Care Costs; Histology; Histopathology; Home; Hospitals; Image; Immunofluorescence Immunologic; Immunohistochemistry; Incidence; Income; Infrastructure; Institutional Review Boards; Intervention; Label; Laboratories; Logistics; Love; Machine Learning; Malignant Neoplasms; Marketing; Mechanics; Methods; Molecular; Molecular Probes; Morphology; Needle biopsy procedure; Needles; Optics; Pathologist; Pathology; Patient Recruitments; Patient Triage; Patients; Performance; Peripheral; Positioning Attribute; Procedures; Process; Protocols documentation; Reagent; Resolution; Resources; Sampling; Services; Slide; Societies; Surgeon; System; Techniques; Technology; Testing; Time; Tissues; Training; Universities; Validation; Visit; Washington; Woman; artificial intelligence algorithm; breast cancer diagnosis; breast lesion; clinical translation; cost; design; digital; digital imaging; experience; global health; histological specimens; imaging approach; imaging system; implementation evaluation; improved; innovation; instrument; low and middle-income countries; low income country; malignant breast neoplasm; member; molecular phenotype; mortality; opportunity cost; peace; phenotypic data; prototype; research clinical testing; success; tissue preparation; tool; treatment planning; usability; validation studies

ABSTRACT Breast cancer is an increasing challenge globally as it became the most prevalent malignancy at the end of 2020. More than 70% of all cancer mortality now occurs in low- and middle-income countries (LMICs). Histology, critical to the diagnosis and disease management for many cancers notably including breast cancer, is currently performed using techniques that are more than 100 years old. Market forces, technological advances in optics, and innovation in care strategies are opening the door for disruptive innovation that could massively reduce costs and time and improve accessibility while provide equivalent or even superior results. We propose to contribute to the field's evolution by combining two already functioning and complementary technologies: 1) a tissue millifluidics approach (developed in PI Seibel's lab) for hands-off core needle biopsy handling; and 2) a rapid, low-cost, direct-to-digital slide-free imaging solution (developed in PI Levenson's lab). The goal is to implement a context-appropriate, automated instrument that can capture diagnostic-quality histopathology images from core-needle biopsies vital to high-quality breast-cancer diagnosis and staging, at time of procedure. Additional project goals include implementation of innovative rapid immunofluorescence methods for near-real-time therapy guidance; and development of AI tools for patient triage or even local diagnostic support, the latter under the direction of Dr. Mahmood (BWH), a leader in multiclass AI algorithms. Key to success of this project is local implementation and clinical evaluation in Kumasi, Ghana, under the direction of Dr. Addai, consultant breast surgeon and CEO of Peace and Love Hospitals (established in 2002). Her group will critically assess performance, usability, and compatibility with the service environment in both a central hospital and a remote satellite clinic; clinical validation studies will eventually encompass at least several hundred patients recruited under IRB-approved protocols. Additional guidance will be provided by Dr. Dan Milner, CMO of the American Society for Clinical Pathology (ASCP), who has extensive experience in global-health-focused initiatives, as well as by our collaborating pathologists who are familiar with issues relevant to LMIC settings. Feedback will inform the design of the second-generation automated instruments to be delivered near the end of this project.

抽象的 乳腺癌在全球范围内是一个日益严峻的挑战，因为它在 20 世纪末成为最常见的恶性肿瘤。 2020 年。目前，所有癌症死亡率的 70% 以上发生在低收入和中等收入国家 (LMIC)。 组织学对于许多癌症（特别是乳腺癌）的诊断和疾病管理至关重要， 目前使用的技术已有 100 多年的历史。市场力量、技术力量 光学的进步和护理策略的创新正在为颠覆性创新打开大门， 大幅降低成本和时间并提高可访问性，同时提供同等甚至更好的结果。 我们建议通过结合两个已经发挥作用且互补的领域来为该领域的发展做出贡献 技术：1) 组织微流体方法（由 PI Seibel 实验室开发），用于不干涉核心针活检 处理； 2) 快速、低成本、直接数字化的无载玻片成像解决方案（由 PI Levenson 实验室开发）。 目标是实现一种适合上下文的自动化仪器，可以捕获诊断质量 来自芯针活检的组织病理学图像对于高质量乳腺癌诊断和分期至关重要， 程序的时间。其他项目目标包括实施创新的快速免疫荧光 近实时治疗指导方法；以及开发用于患者分诊甚至本地的人工智能工具 诊断支持，后者由多类人工智能算法领域的领导者 Mahmood 博士 (BWH) 指导。 该项目成功的关键是在加纳库马西的当地实施和临床评估， 乳腺外科医生顾问兼和平与爱医院（成立于 2002 年）首席执行官 Addai 博士的指导下。 她的团队将严格评估性能、可用​​性以及与服务环境的兼容性 中心医院和远程卫星诊所；临床验证研究最终将至少涵盖 根据 IRB 批准的方案招募了数百名患者。博士将提供额外的指导。 Dan Milner，美国临床病理学会（ASCP）首席营销官，在以下方面拥有丰富的经验： 以全球健康为重点的倡议，以及我们熟悉问题的合作病理学家的倡议 与 LMIC 设置相关。反馈将为第二代自动化仪器的设计提供信息 将在该项目接近尾声时交付。