Leveraging Label-Free Digital Imaging to Enable Rapid On-Site Evaluation (ROSE) During Thyroid Biopsy Procedures

利用无标记数字成像在甲状腺活检过程中实现快速现场评估 (ROSE)

• 批准号: 10756316
• 负责人: Troy Holsing
• 金额: $ 40万
• 依托单位: PATHWARE INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-03 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10756316
• 关键词: Adoption; Algorithms; Area; Artificial Intelligence; Attention; Benign; Biopsy; Biopsy Specimen; Cells; Cellularity; Clinical; Code; Collaborations; Colorado; Computer software; Cytology; Data; Detection; Development; Diagnosis; Diagnostic; Evaluation; Evolution; Excision; Face; Fine needle aspiration biopsy; Funding; Future; Glass; Goals; Grant; Hospitals; Image; Incidence; Label; Literature; Location; Lung; Methods; Microscope; Microscopic; Microscopy; Modality; Modeling; Nightmare; Operative Surgical Procedures; Optics; Pathologist; Pathology; Patient Care; Patients; Phase; Physicians; Procedures; Reporting; Research; Resources; Risk; Sampling; Scanning; Schools; Site; Slide; Specimen; Stains; Stream; Surface; System; Technology; Telepathology; Thick; Thyroid Gland; Thyroid Nodule; Thyroidectomy; Time; Training; Unnecessary Surgery; algorithm training; artificial intelligence algorithm; blind; clinical application; commercialization; computer aided detection; digital; digital imaging; experience; imaging platform; innovation; interest; live stream; novel; point of care; point-of-care diagnostics; prototype; rapid detection; risk mitigation; robotic microscopy; standard of care; transfer learning; usability; validation studies

Project Summary/Abstract Pathware is developing Bioptic™, an imaging platform to analyze biopsy samples at the point-of-care. The system will rapidly digitize unstained biopsy samples and utilize computer-aided detection/diagnostics to enable quick and efficient evaluations by pathologists. Typical barriers to point-of-care diagnostics are overcome by combining novel computational microscopy with AI (Artificial Intelligence) algorithms to direct on-site or remote pathologists to regions of clinical interest. This proposed research's broad, long-term objective is to enable real- time diagnostics of pathology samples at the point-of-care. Thyroid nodules have a high incidence rate, and assessment via fine-needle aspiration (FNA) biopsy is often an integral step in the diagnostic pipeline. The biopsy samples are frequently inadequate for diagnosis resulting in repeat biopsies or unnecessary surgical resections. Rapid On-Site Evaluation (ROSE) for sample adequacy is ideal for patient care, because it mitigates the risk of inadequate samples by verifying diagnostic quality at the point-of-care. Despite the high incidence of inadequate biopsies, ROSE is performed in less than 25% of thyroid biopsy procedures due to financial and operational barriers, including pathologist availability. The current alternatives to ROSE (telepathology, robotic microscopy, and live-streaming microscopy) are plagued by barriers to adoption due to the requirement of staining samples, technical challenges, and regulatory limitations. AI- assisted ROSE has the potential to overcome these barriers and provide a superior standard-of-care. The immediate goals of the proposed project are to 1) demonstrate non-destructive imaging of unstained thyroid cytology smears with a novel microscopy modality and 2) train AI algorithms on the acquired images for future development of computer-aided detection algorithms for ROSE adequacy assessments.

项目摘要/摘要 Pareware正在开发Bioptic™，这是一个成像平台，可在护理点分析活检样品。这 系统将迅速数字化未染色的活检样本，并利用计算机辅助检测/诊断启用 病理学家的快速评估。通过 将新颖的计算显微镜与AI（人工智能）算法结合到现场或远程 病理学家到临床关注区域。这项拟议的研究的广泛长期目标是实现现实 病理样本的时间诊断。 甲状腺结节的发病率较高，并且通过细针吸入（FNA）活检评估通常是 诊断管道中的整体步骤。活检样本通常不足以进行诊断，从而 重复活检或不必要的手术切除。快速现场评估（ROSE）用于样品充足性 非常适合患者护理，因为它通过验证诊断质量在 护理点。尽管活检不足的事件很高，但在不到25％的甲状腺中进行了玫瑰 由于财务和操作障碍，包括病理学家的可用性，活检程序。电流 玫瑰的替代方案（远程病理学，机器人显微镜和实时流程显微镜）受到障碍的困扰 由于需要染色样本，技术挑战和监管限制，因此采用。人工智能- 辅助玫瑰有可能克服这些障碍并提供出色的护理标准。 拟议项目的直接目标是1）证明未染色甲状腺的非破坏性成像 具有新型显微镜模态的细胞学涂片和2）在获得的图像上训练AI AI算法以备将来 开发用于玫瑰充分评估的计算机辅助检测算法​​。