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A Low-Cost, Portable Guidance System for Needle Biopsy

低成本、便携式穿刺活检引导系统

基本信息

批准号：
8706148
负责人：
Philipp Stolka
金额：
$ 20万
依托单位：
CLEAR GUIDE MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-01 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8706148
关键词：
Algorithms Animal Model Animals Area Baltimore Biopsy Calibration Clinic Collaborations Detection Development Device or Instrument Development Devices Diagnostic Diagnostic tests Disease Distant Economics Educational Status Evaluation Feedback Funding Opportunities General Practitioners Gold Health Health Personnel Health Professional Health Services Accessibility Human Resources Image In Situ Intervention Lesion Life Light Liver diseases Location Malignant Neoplasms Marketing Medical Device Methods Needle biopsy procedure Needles Outcome Patients Phase Physicians Positioning Attribute Price Primary Health Care Procedures Relative (related person)Rural Rural Population Series Site Staging Structure Surface System Systems Development Technology Training Ultrasonography Underserved Population Vendor Work X-Ray Computed Tomography base cancer diagnosis cost cost effective design experience health disparity image guided intervention in vivo innovation innovative technologies insight phantom model prototype public health relevance radiologist skills skills training software systems usability

项目摘要

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.

描述（由申请人提供）：通过经皮穿刺活检进行早期疾病检测被认为是癌症诊断的金标准，因此可以获得良好的健康结果。该项目旨在通过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，来改善健康差距。关键的使能技术是一种基于超声的引导系统，旨在提供直观和可靠的原位引导，可由经过最少培训的介入医生使用，使医生能够在自己的诊所或办公室对患者进行穿刺活检。该项目包括三个目标。第一个目标是开发和评估一种易于使用的导向系统，用于靶向穿刺活检，重点是导向平台本身的开发，包括设备构造、内部校准、超声系统接口以及几种导向模式的开发。第二个目标是通过提供新的超声和表面到CT配准算法，将术前CT和超声之间的配准扩展到图像引导介入的引导系统，使关键结构的专家注释能够直接传输到引导系统。第三个目标是由不同技能和培训水平的从业者在体模模型和试点动物研究中评估该系统，并将其与最先进的引导系统进行比较。第三个目标包括建立一个健康差距咨询委员会，指导进一步开发该设备，以减少农村和服务不足人口的健康差距。