Copy of Development of methods for characterising and testing clinical High Intensity Focused Ultrasound (HIFU) systems

临床应用高强度聚焦超声（HIFU）治疗软组织癌，如肝癌、肾癌和前列腺癌，是一个年轻而迅速发展的领域。迄今为止，全世界已有3万多名患者接受了治疗。当肿瘤的温度升高到瞬间细胞死亡的水平时，治疗就成功了。聚焦的光束确保只有被瞄准的组织被加热，而周围的组织不受伤害。安全有效地使用HIFU需要尽快提供经过验证的临床设备测量和测试方法。到目前为止，这些问题还没有得到任何系统的处理。临床HIFU系统目前由个别临床部门和制造商进行临时评估，使用的方法，其中许多未发表。因此，迫切需要生产标准的注册和测试设备和方法，使用户能够表征临床HIFU系统，以检查机器输出的安全性和可重复性，比较不同的设备或调试新系统。拟议的工作方案是对现有技术和新兴技术进行调整和推广，以满足这种新的医疗技术的要求，并开发专门用于这种应用的新方法。本项目的总体目标是通过：A.提高临床HIFU治疗的有效性、安全性和适用范围。*使用压力场测绘和声功率测量技术进行超声场表征；*利用电阻抗测量和实时声功率测量进行患者暴露监测；C.在癌症研究所（ICR）建立世界领先的HIFU表征设施；通过：*科学出版物向更广泛的用户群传播成功的方法、协议和设备；*对国家和国际标准的书面贡献；*商业开发。

The clinical application of high intensity focused ultrasound (HIFU) to the treatment of soft tissue cancers of, for example, the liver, kidney and prostate, is a young and rapidly expanding field. To date more than 30,000 patients have been treated world wide. Successful treatment is achieved when the temperature of the tumour is raised to levels at which instantaneous cell death occurs. The focused beam ensures that only the tissue being targeted is heated, whilst surrounding tissue remains unharmed. Safe and effective use of HIFU requires that validated methods for measurement and testing of clinical devices should be made available as soon as possible. These issues have not been addressed to date in any systematic fashion. Clinical HIFU systems are currently assessed on an ad hoc basis by individual clinical departments and manufacturers, using methods, many of which are unpublished. There is, therefore, an urgent need to produce standard registration and testing equipment and methodology that allows users to characterize clinical HIFU systems for the purposes of checking safety and reproducibility of a machine's output, comparing different devices or commissioning new systems. The programme of work proposed is a mixture of adaptation and extension of existing and emerging techniques to meet the requirements of this new medical technology, and the development of novel methods specifically for this application.The overall aim of this project is to improve the efficacy, safety and range of applicability of clinical HIFU treatments by:A. providing validated methods for: * ultrasonic field characterisation using pressure field mapping and acoustic power measurement techniques; * HIFU system performance testing and quality assurance using novel thermal and cavitation mapping methods * patient exposure monitoring by means of electrical impedance measurements and real time acoustic power measurement;B. establishing a world leading HIFU characterisation facility at the Institute of Cancer Research (ICR);C. disseminating the successful methods, protocols and equipment to a wider user base through: * scientific publication; * contribution to written National and International Standards; * commercial exploitation.