A Low-Cost, Portable Guidance System for Needle Biopsy

描述(申请人提供)：通过经皮针刺活检早期发现疾病被认为是癌症诊断的黄金标准，因此也是获得良好健康结果的金标准。该项目旨在改善健康差距，使全科医生和其他卫生专业人员能够在自己的办公室或诊所进行图像引导的针吸活检，而不是将可疑病变的患者送到遥远的中心。这项关键技术是一种基于超声波的引导系统，旨在提供直观可靠的原位引导，干预者只需接受最少的培训即可使用，使医生能够在自己的诊所或办公室对患者进行针刺活组织检查。该项目由三个目标组成。第一个目标是开发和评估一种易于使用的靶向活检引导系统，重点是引导平台本身的开发，包括设备结构、内部校准、与超声系统的接口以及几种引导模式的开发。第二个目标是通过提供超声和表面到CT的配准的新算法，将术前CT和超声之间的配准扩展到导航系统，使关键结构的专家注释能够直接传输到导航系统。第三个目标是在幻影模型和由不同技能和培训水平的从业者进行的试点动物研究中对该系统进行评估，并将其与最先进的指导系统进行比较。第三个目标包括建立一个健康差距咨询委员会，以指导进一步开发部署该设备，以减少农村和服务不足人口的健康差距。

DESCRIPTION (provided by applicant): Early disease detection through percutaneous needle biopsies is considered the gold standard for cancer diagnoses and thus for obtaining good health outcomes. This project seeks to ameliorate health disparities by making it possible for general practitioners and other health professionals to perform image-guided needle biopsies in their own office or clinic rather than sending patients with suspect lesions to distant centers. Th key enabling technology is an ultrasound-based guidance system designed to provide intuitive and reliable in-situ guidance that can be used by interventionalists with minimal training, allowing doctors to perform needle biopsies on patients in their own clinic or office. The project consists of three aims. The first aim will develop and evaluate an easy-to-use guidance system for targeted needle biopsy by focusing on the development of the guidance platform itself, including device construction, internal calibration, interfaces to the ultrasound system, and the development of several guidance modes. The second aim will extend guidance system with registration between pre-operative CT and ultrasound foriImage-guided interventions, by providing new algorithms for ultrasound- and surface- to CT registration, making it possible for expert annotations of critical structures to be transferred to the guidance system directly. The third aim will evaluate the system on phantom models and in a pilot animal study by practitioners of varying skill and training levels, and comparing it to state-of-the-art guidance systems. The third aim includes the creation of a health disparity advisory board to guide the further development of the device for deployment to reduce health disparities in rural and underserved populations.