Imaging Goggles for Fluorescence-Guided Surgery

用于荧光引导手术的成像护目镜

• 批准号: 10609673
• 负责人: Samuel Achilefu
• 金额: $ 58.5万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10609673
• 关键词: 3-Dimensional; Address; Adoption; Algorithms; Animal Cancer Model; Area; Augmented Reality; Beds; Biological; Blood flow; Breast-Conserving Surgery; Calibration; Cancer Patient; Clinic; Clinical; Clinical Research; Collaborations; Color; Computer software; Consumption; Data; Decision Making; Development; Devices; Digital Imaging and Communications in Medicine; Disease; Dyes; Engineering; Ensure; Evaluation; Excision; Feedback; Fluorescence; Frozen Sections; Goals; Goggles; Growth; Head Cancer; Histology; Hospitals; Human; Image; Image-Guided Surgery; Imaging Device; Incidence; Infiltration; Infrastructure; Intervention; Intuition; Left; Lesion; Machine Learning; Malignant Neoplasms; Medical; Medical Device; Medical center; Metadata; Methods; Microscopic; Molecular Probes; Molecular Target; Near-infrared optical imaging; Neck Cancer; Noninfiltrating Intraductal Carcinoma; Oncology; Operating Rooms; Operative Surgical Procedures; Optical Methods; Optics; Outcome; Pathology; Pathology Report; Patient-Focused Outcomes; Patients; Pattern; Performance; Pilot Projects; Real-Time Systems; Reporting; Reproducibility; Research; Resource-limited setting; Resources; Role; Rural; Rural Hospitals; Savings; Solid Neoplasm; Specimen; Stream; Surgeon; Surgical Oncology; Surgical margins; System; Tactile; Testing; Thick; Time; Tissue imaging; Tissues; Training; Treatment outcome; Vision; Visual; Visual Fields; absorption; cancer cell; cancer imaging; cancer recurrence; cancer surgery; clinical center; clinical translation; cost; design; ergonomics; experience; fluorescence imaging; fluorescence-guided surgery; head mounted display; image processing; image registration; imaging system; improved; industry partner; infiltrating duct carcinoma; interest; lens; mixed reality; neoplastic cell; operation; optical imaging; peripheral blood; phantom model; portability; prevent; radiological imaging; software development; standard of care; stem; tumor; user-friendly; wearable device; workforce needs

Interest in the use of optical imaging instruments in medical interventions stems from their ease of use, rapid adaptation to clinical needs, portability, real-time feedback, and relatively low cost. Of particular interest is the role of optical imaging in oncology. Surgery is the primary curative method for solid tumors confined to the tissue of origin with the goal of completely removing both the tumor mass and microscopic lesions. Unfortunately, the irregular growth pattern and infiltrations into surrounding healthy tissue prevent complete removal in many cases, resulting in positive surgical margins (PSMs). PSMs are prevalent in oncologic surgery, increasing cancer recurrence rates and often necessitates a second surgery to improve disease-specific survival. While PSM occurrence is significant in advanced clinical centers, the situation is worse in many rural hospitals and resource- limited areas due to limited histology infrastructure and workforce needed for margin assessment. Thus there is an urgent need for an intraoperative imaging system to visualize cancer, guide tumor removal, and determine margin positivity in the operating room (OR) in low and high resource settings alike. Handheld fluorescence imaging systems have been developed to aid cancer resection. Still, they suffer from several limitations, including a significant footprint in the OR and the inability of the operating surgeon to directly control the imaging device while performing surgery. To address these shortcomings, we developed a head- mounted display device (HMD) cancer imaging system for real-time intraoperative fluorescence-guided surgery (FGS). The system HMD captures near-infrared (NIR) fluorescence and color images from the surgical bed and displays accurately aligned color-NIR images in real-time, enabling FGS without disrupting surgical workflow. The HMD has a small footprint, is intuitive to use, and is amenable for widespread use, including non-cancer applications such as imaging of peripheral blood flow. Preliminary testing of the HMD system in human cancer patients identified some areas for improvement that will accelerate the eventual clinical adoption of the system worldwide. Addressing these needs requires expertise in packaging software development for medical devices with DICOM image format and user interface development using human factors engineering. We have teamed up with a company that has both expertise and experience in developing augmented reality/mixed reality (AR/VR) software combined with deep machine learning in wearable devices on this project. Together, we will optimize the system performance and ergonomics using human factors engineering. The collaborative project will (1) develop and validate an automated fluorescence thresholding algorithm for tumor delineation; (2) develop and validate automated registration of augmented reality in the system; and (3) develop and evaluate clinical software to improve user experience. At the completion of this project, we expect to develop and validate a clinic-ready, user-friendly HMD system with a small hardware footprint, enabling seamless integration with surgical workflow to enhance clinical adoption. The system will increase the rates and decrease the time of successful tumor resection. Anticipated low cost and ease of use will expand adoption in low and high resource settings worldwide. This objective approach to cancer surgery will reduce the incidence of PSMs and improve treatment outcomes.

在医疗干预中使用光学成像仪器的兴趣源于它们的易用性、快速性和可操作性。 适应临床需要、便携性、实时反馈和相对低的成本。特别感兴趣的是 光学成像在肿瘤学中的作用。手术是局限于组织的实体瘤的主要治疗方法 目的是完全去除肿瘤块和显微病变。可惜 不规则的生长模式和向周围健康组织的浸润在许多情况下阻止了完全去除， 导致手术切缘阳性（PSM）。PSM在肿瘤手术中很普遍， 复发率，往往需要第二次手术，以提高疾病特异性生存。虽然PSM 发生在高级临床中心，许多农村医院和资源中心的情况更糟， 由于有限的组织学基础设施和边缘评估所需的劳动力，区域有限。因此存在 迫切需要一种术中成像系统来可视化癌症，引导肿瘤切除，并确定 在低和高资源设置下，手术室（OR）中的边际积极性相似。 手持式荧光成像系统已经被开发用于辅助癌症切除。但是，他们仍然遭受着 几个局限性，包括手术室中的显著足迹和手术外科医生无法直接 在执行手术时控制成像设备。为了解决这些问题，我们开发了一个头部- 用于实时术中荧光引导手术的安装式显示装置（HMD）癌症成像系统 （FGS）。系统HMD从手术床捕获近红外（NIR）荧光和彩色图像， 实时显示精确对齐的彩色近红外图像，实现FGS而不会中断手术工作流程。 HMD占地面积小，使用直观，适合广泛使用，包括非癌症 例如外周血流成像的应用。HMD系统在人类癌症中的初步测试 患者确定了一些需要改进的领域，这将加速该系统的最终临床采用 国际吧满足这些需求需要医疗设备包装软件开发方面的专业知识 DICOM图像格式和用户界面开发使用人因工程。我们联手 与一家在开发增强现实/混合现实方面拥有专业知识和经验的公司合作 (AR/VR）软件结合深度机器学习在可穿戴设备上的这个项目。我们将共同 使用人因工程优化系统性能和人体工程学。合作项目 将（1）开发和验证用于肿瘤描绘的自动荧光阈值算法;（2）开发 并验证系统中增强现实的自动注册;以及（3）开发和评估临床 软件，以改善用户体验。 在这个项目完成后，我们希望开发和验证一个临床就绪，用户友好的HMD系统 硬件占用空间小，能够与手术工作流程无缝集成， 领养该系统将提高肿瘤切除的成功率并缩短肿瘤切除的时间。预期 低成本和易用性将在全世界低资源和高资源环境中扩大采用。这一目标 癌症手术的方法将减少PSM的发生率并改善治疗结果。