放射治疗用锥形束CT图像引导设备技术审评要求探讨.PDFVIP

第35 卷 第9 期 中国医学物理学杂志 Vol. 35 No.9 2018 年 9 月 Chinese Journal of Medical Physics September 2018 DOI: 10.3969/j.issn. 1005-202X.2018.09.001 医学放射物理 放射治疗用锥形束CT 图像引导设备技术审评要求探讨 谷晓芳 国家食品药品监督管理总局医疗器械技术审评中心，北京 100081 【摘 要】主要分析放射治疗kV 级锥形束CT（CBCT）图像引导系统和诊断用扇形束CT 的技术原理及临床应用的差异，包 括数据获取方式、图像处理方式、空间分辨率、成像剂量、图像噪声、密度分辨率等方面的差异，从而进一步分析CBCT 和 扇形束CT技术审评要求中电气安全、性能指标等要求的差异，以及CBCT 说明书、注册单元划分的要求，预期为制造商准 备CBCT 图像引导系统的注册申报资料提供参考。 【关键词】锥形束CT；扇形束CT；图像引导系统；技术审评；电气安全；性能指标 【中图分类号】R318.6 ；R 197.39 【文献标志码】A 【文章编号】1005-202X（2018）09-0993-04 Requirements for technical review of CBCT image-guided radiotherapy system GU Xiaofang Center for Medical Device Evaluation, China Food and Drug Administration, Beijing 100081, China Abstract:The differences in technical principles and clinical applications between kV-cone beam computed tomography (CBCT) image-guided radiotherapy system and fan beam CT for diagnosis were analyzed, including differences in data acquisition, image processing, spatial resolution, imaging dose, image noise, density resolution and so on. The differences in the requirements for electrical safety and performance indexes in the technical review of CBCT and fan beam CT were further analyzed. Then the requirements for CBCT user manual and registration unit division were also discussed. This analysis aims to provide some references for manufacturers to apply for the registration of CBCT image-guided radiotherapy system. Keywords:cone beam computed tomography; fan beam computed tomography; image-guided system; technical review; electrical safety; performance indexes 前 言 动）和分次间的位移误差（如日常摆位误差、靶区收 缩等引起肿瘤和周围正常组织相对位置变化）对放 放射治疗中患者肿瘤位置准确性是影响治疗效