DEVELOPMENT OF GOGGLE SYSTEM FOR FLUORESCENCE IMAGE-GUIDED SURGERY

荧光图像引导手术护目镜系统的开发

• 批准号: 8605861
• 负责人: Samuel Achilefu
• 金额: $ 55.83万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-16 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8605861
• 关键词: Address; Adopted; Animal Model; Animals; Biological; Biomedical Engineering; Body part; Brain; Breast Cancer Model; Cancer Patient; Cancerous; Canis familiaris; Cells; Clinic; Clinical; Communication; Complement; Complex; Coupling; Data; Detection; Development; Devices; Environment; Excision; Eye; Feedback; Fluorescence; Fluorescent Dyes; Fright; Future; Goals; Goggles; Hand; Head; Human; Image; Image Analysis; Image-Guided Surgery; Imaging Techniques; Investigational Drugs; Label; Learning; Life; Magnetic Resonance; Magnetic Resonance Imaging; Malignant Neoplasms; Medical; Methods; Microscopic; Molecular Probes; Monitor; Mouse Mammary Tumor Virus; Nodule; Nonionizing Radiation; Operating Rooms; Operative Surgical Procedures; Optics; Patients; Performance; Pharmacology; Physiology; Preclinical Testing; Prevalence; Procedures; Proliferating; Property; Real-Time Systems; Reliance; Research; Research Personnel; Research Project Grants; Resolution; Resources; Safety; Sampling; Scheme; Scientist; Sensitivity and Specificity; Site; Solid Neoplasm; Staging; Staining method; Stains; Stress; Surgeon; Surgical margins; System; Technology; Telemedicine; Three-Dimensional Imaging; Time; Tissues; Transgenic Mice; Veterinary Surgery; Visit; Wireless Technology; Work; X-Ray Computed Tomography; base; cancer care; cancer therapy; computer monitor; cost; data acquisition; fluorescence imaging; improved; in vivo; instrument; instrumentation; intraoperative imaging; malignant breast neoplasm; molecular imaging; novel; optical imaging; portability; pre-clinical; preclinical toxicity; prevent; prototype; public health relevance; research clinical testing; response; rural area; tool; tumor; tumor eradication; user-friendly

DESCRIPTION (provided by applicant): Although new cancer treatment methods developed in the past decade have shown promise in minimally or noninvasive eradication of tumors, surgery remains the primary treatment paradigm for most solid tumors. Surgeons previously relied on pre-operative images for tumor resection, but recent efforts to provide image guidance in the operating room have significantly improved tumor localization. Optical imaging techniques, in particular, have found a niche in the operating room because of their relatively low cost, use of non-ionizing radiation, fast data acquisition, and real-time image guidance. However, microscopic optical technologies have small field of view, which confines their use to sampling small tissue volumes. Current intraoperative planar imaging systems display 2D images on computer monitors, requiring the surgeon to alternate between the surgical site and the monitor. The large size of these systems challenges their use in small surgical suites and hampers portability. Tomographic approaches are capable of 3D display, but the complex instrumentation and intensive image analysis precludes real-time feedback and may require steep learning curve for operators. Another related overarching problem is the prevalence of positive surgical margins because of the lack of a reliable imaging agent for intraoperative surgical margin assessment, leading to costly repeat visits. Therefore, there is a compelling need to develop an accurate, affordable, user-friendly, portable, and versatile intraoperative imaging system with real-time imaging capability. The technology platform should also be able of providing real-time assessment of surgical margins. To accomplish these goals, we will develop an intra-operative near-infrared (NIR) fluorescence/reflectance 3D imaging goggle system that can accurately image tumor boundaries, small positive nodules, and provide image guidance in real-time. Intraoperative surgical margin assessment will be aided by a tumor-selective optical imaging agent optimized for the goggle system. At the development stage, the goggle system will use information from the molecular probe to optimize the detection scheme. Specifically, we will develop and optimize a hands-free 3D head-mounted fluorescence imaging and display system, and a near infrared imaging agent for in vivo staining of tumor margins. We will then use the goggle system for molecular imaging of small animal models of breast cancer, as well as canine breast cancer patients. Pharmacology and safety data generated from these studies will be used for investigational new drug (IND) and device exemption (IDE) application to the FDA.

描述（由申请人提供）：尽管过去十年开发的新癌症治疗方法已显示出微创或无创根除肿瘤的前景，但手术仍然是大多数实体瘤的主要治疗范例。外科医生以前依靠术前图像进行肿瘤切除，但最近在手术室提供图像引导的努力显着改善了肿瘤定位。尤其是光学成像技术，由于其成本相对较低、使用非电离辐射、快速数据采集和实时图像引导，在手术室中占有一席之地。然而，显微光学技术的视野较小，这限制了其用于对小组织体积进行采样。目前的术中平面成像系统在计算机显示器上显示 2D 图像，要求外科医生在手术部位和显示器之间交替。这些系统的大尺寸对其在小型手术室中的使用提出了挑战，并妨碍了便携性。断层扫描方法能够进行 3D 显示，但复杂的仪器和密集的图像分析妨碍了实时反馈，并且可能需要操作员陡峭的学习曲线。另一个相关的总体问题是由于缺乏可靠的成像剂用于术中手术切缘评估而导致手术切缘阳性的普遍存在，导致重复就诊的成本高昂。因此，迫切需要开发一种准确、价格实惠、用户友好、便携式、多功能且具有实时成像功能的术中成像系统。该技术平台还应该能够提供手术边缘的实时评估。为了实现这些目标，我们将开发一种术中近红外（NIR）荧光/反射3D成像护目镜系统，该系统可以准确地对肿瘤边界、小阳性结节进行成像，并提供实时图像引导。针对护目镜系统优化的肿瘤选择性光学成像剂将有助于术中手术切缘评估。在开发阶段，护目镜系统将利用分子探针的信息来优化检测方案。具体来说，我们将开发和优化免提3D头戴式荧光成像和显示系统，以及用于肿瘤边缘体内染色的近红外成像剂。然后，我们将使用护目镜系统对小动物乳腺癌模型以及犬乳腺癌患者进行分子成像。这些研究产生的药理学和安全性数据将用于向 FDA 申请研究性新药 (IND) 和器械豁免 (IDE)。