项目来源

国家重点研发计划(NKRD)

项目主持人

张龙江

项目受资助机构

中国人民解放军南京军区南京总医院

立项年度

2017

立项时间

未公开

项目编号

2017YFC0113400

研究期限

未知 / 未知

项目级别

国家级

受资助金额

1152.00万元

学科

数字诊疗装备研发

学科代码

未公开

基金类别

“数字诊疗装备研发”重点专项

关键词

CT ; 低剂量X线 ; 评价 ; 辐射剂量 ; Low-dose X-ray ; Evaluation ; Radiation dose

参与者

未公开

参与机构

东部战区总医院

项目标书摘要：影像学检查，尤其是 CT 已成为疾病诊疗不可或缺的检查手段。国内对 CT 和 X 线机产品有很大的需求量，是一个巨大的潜在市场。尽管国内 CT 和 X 线机产品制造商在努力赶超国际同行，但因各厂商水平参差不齐，市场鱼龙混杂，现有的国内外相关标准尚不规范统一，产品评价仍缺乏系统的科学指导。在建设创新型国家的大背景下，开展国产 CT 和低剂量 X 线机产品临床评价研究，寻找差距并努力赶超国际水平使国产设备不仅在国内成为主流产品且能跻身国际主流产品行列，已势在必行，刻不容缓。针对上述关键科学问题，本研究对国产 CT 和低剂量 X 线机产品的国内发展需求、技术性能和临床功能等进行系统评价研究，并创新性地将辐射剂量管理及影像数据管理纳入评价系统中。以主流国产创新产品为主，代表性进口产品为参照进行全面系统的临床功能测试评价，最终完成产品评价报告，发表医用 CT 及低剂量X 线机评价体系指南。通过质量功能展开方法进行 CT 及低剂量 X 线机产品需求分析。在现有评价标准基础上，结合需求分析报告不断优化和拓展，建立系统科学的 CT 及低剂量 X 线机产品技术性能评价规范体系；在临床功能领域，以国外高端 CT 为参照，以主流国产创新 CT 为主要评价对象，对其常规及高端临床功能(包括后处理工作站),如 CT 灌注成像、低剂量 CT血管成像等的图像质量和诊断准确性等进行系统评价。

Application Abstract: Imaging examination,especially CT has become an indispensable inspection method for disease diagnosis and treatment.There is a large demand for CT and X-ray machines in China,which is a huge potential market.Although domestic manufacturers of CT and X-ray machines are struggling to catch up with their international counterparts,due to the varying levels of various manufacturers and the mixed market,the existing domestic and international standards are not standardized and unified,and product evaluation still lacks systematic scientific guidance.Under the background of building an innovative country,we have conducted clinical evaluation research on domestic CT and low-dose X-ray machine products,looking for gaps and striving to catch up with international standards.Domestic equipment has become not only a mainstream product in China but also among the mainstream international products.It is imperative and urgent.In response to the above-mentioned key scientific issues,this study systematically evaluates the domestic development needs,technical performance,and clinical functions of domestic CT and low-dose X-ray machine products,and innovatively incorporates radiation dose management and image data management into the evaluation system..Based on mainstream domestic innovative products and representative imported products as reference,a comprehensive and systematic clinical function test and evaluation will be completed.The final product evaluation report will be completed,and guidelines for medical CT and low-dose X-ray machine evaluation systems will be published.Product quality analysis of CT and low-dose X-ray machines was performed by mass function deployment method.Based on the existing evaluation standards,combined with the needs analysis report to continuously optimize and expand,establish a systematic scientific CT and low-dose X-ray machine product technical performance evaluation specification system;in the field of clinical functions,take foreign high-end CT as a reference,and mainstream domestic production Innovative CT is the main evaluation object,and systematically evaluates its routine and high-end clinical functions(including post-processing workstations),such as image quality and diagnostic accuracy of CT perfusion imaging,low-dose CT angiography,and so on.

项目受资助省

江苏省

项目实施周期(年)

3