摘要
目的 通过临床验证获得临床影像质量可接受率、设备常用功能、机器使用便捷性、整机稳定性满意度与安全性评价,对Insight NM/CT Pro SPECT/CT成像系统临床应用中的安全性与有效性进行验证。资料与方法 前瞻性选取内蒙古医科大学附属医院2022年7—10月自愿参与试验的受试者79例,使用Insight NM/CT Pro SPECT/CT分别进行内分泌、循环、骨骼、呼吸、泌尿多系统显像,对图像质量进行有效性评价,并评价机器运行情况与安全性。结果 79例患者影像质量评价:平面显像36例中可接受者35例;断层显像43例中可接受者42例,可接受率分别为97.22%、97.67%,95%CI下限分别为85.47%、87.71%,均高于目标值(83.00%)。操作人员对79例患者进行显像操作时,设备常用功能、设备使用便捷性、整机稳定性评价均满意,满意率为100%,未发生不良事件。结论 Insight NM/CT Pro SPECT/CT有效性可满足临床应用要求,图像组织结构显示清楚,设备常用功能齐备,系统稳定,安全性较高。
Purpose To verify the safety and effectiveness of the Insight NM/CT Pro SPECT/CT Imaging System in clinical applications is verified through clinical validation of the acceptable rate of clinical image quality,commonly use features of the device,ease of use of the machine,satisfaction with the stability of the entire machine and safety evaluation.Materials and Methods A total of 79 subjects who voluntarily participated in the trial from July to October 2022 in the Affiliated Hospital of Inner Mongolia Medical University,were selected to undergo endocrine,circulatory,skeletal,respiratory and urological imaging for multiple systems using the Insight NM/CT Pro SPECT/CT,respectively.The quality of the images,the machine operation and safety were evaluated.Results The image quality of all 79 patients were evaluated.Of 36 cases,there were 35 cases of planar imaging were acceptable;Of 43 cases,there were 42 cases of tomographic imaging were acceptable,with an acceptability rate of 97.22%and 97.67%,respectively,and a lower limit of 95%CI of 85.47%and 87.71%,respectively,which were both higher than those of the target value(83.00%).When the operators performed imaging operations on 79 patients,the common functions of the equipment,the ease of use of the equipment and the stability of the whole machine were evaluated as a satisfaction rate of 100%,with no adverse events.Conclusion Insight NM/CT Pro SPECT/CT effectiveness fully meets the requirements of clinical applications,with clear images of tissue structure,full range of commonly used equipment features,stable system,and superior safety and reliability.
作者
马旭
王雪梅
张国建
李剑波
高丽蕾
刘帆
MA Xu;WANG Xuemei;ZHANG Guojian;LI Jianbo;GAO Lilei;LIU Fan(不详;Department of Nuclear Medicine,the Affiliated Hospital of Inner Mongolia Medical University,Hohhot 010050,China;Inner Mongolia Key Laboratory of Molecular Imaging,Hohhot 010050,China)
出处
《中国医学影像学杂志》
CSCD
北大核心
2024年第11期1170-1175,共6页
Chinese Journal of Medical Imaging
基金
国家重点研发计划“诊疗装备与生物医用材料”重点专项(2022YFC2403804)。
关键词
单光子发射计算机断层摄影术
影像质量
平面成像
断层成像
Single photon emission computed tomography computed tomography
Image quality
Planar imaging
Tomographic imaging
