国产BHP6601型SPECT临床验证方案

Clinical Verification Protocols for Domestically manufactured BHP6601 SPECT

目的 :建立和评价国产SPECT的临床验证标准。材料和方法 :参照国家关于新药临床验证的指导原则和核医学操作规范 ,设计以西门子ECAM型SPECT为对照机型 ,通过临床 15 0例受检者 ,动物实验 44只 ,多种采集、处理方式对比研究的方式 ,进行国产BHP660 1型SPECT临床验证。结果 :二种设备各种采集方式、条件、数据分析、图像处理方面基本相同 ,检出病灶数相近 ( 15 1和 15 3 ) ,动态、断层、门控显像检测效率和所测参数基本一致。动物显像效果相同。结论 :基于临床病例全方位性能比较方式的影像设备临床验证方案客观可靠 ,有可操作性。

Purpose: To design a protocol for clinically verification of a domestically manufactured SPECT(BHP6601). Materials and Methods: Consulting the guidelines for new drug clinical trials and the principle of standard of nuclear medicine practice, a comparative protocol on acquisition, image-processing, data management and clinical performance was carried out with BHP6601 and an imported device(E.Cam, Siemens, USA) on 150 subjects and 44 animals. Results: The functional and clinical performances of the two equipments was virtually similar, with detected lesions of 151 and 153 respectively. The parameters assessed with the two devices were also indifferent. Both devices provided satisfactory animal experimental data. Conclusion: The current verification protocol for BHP6601 was practical and meaningful.