基于自动乳腺超声远程阅片模式进行乳腺癌筛查的前瞻性多中心队列研究

Prospective multicenter cohort study on breast cancer screening using an automated breast ultrasound with remote reading

目的构建基于自动乳腺超声(ABUS)远程阅片模式的乳腺癌筛查网络,探讨ABUS远程阅片模式用于乳腺癌筛查的价值。方法构建包括1个远程阅片中心和48个图像采集中心的远程乳腺癌筛查网络。2021年1月至2023年1月在各图像采集中心连续招募参与乳腺癌筛查的女性,由技师操作ABUS采集全乳标准化超声图像,通过PVBUS系统传输至远程阅片中心,由2位医师分别独立阅片并出具筛查报告。美国放射学会的乳腺成像报告和数据系统(BI-RADS)1类和2类为筛查结果阴性,建议筛查对象每年进行1次乳腺超声检查;BI-RADS 3类、4类和5类为筛查结果阳性,BI-RADS 3类者建议每6个月进行1次乳腺超声检查,BI-RADS 4类和5类者建议进行病理学检查。结果共纳入完成ABUS筛查并随访满12个月女性10344人。经远程阅片诊断为BI-RADS 1类6164人,2类2626人,3类1404人,4类135人,5类15人。ABUS筛查阳性率为15.0%(1554/10344)。ABUS远程阅片模式用于乳腺癌筛查的检出率为3.7/1000(38/10344),灵敏度为97.4%(38/39),特异度为85.3%(8789/10305)。检出的38例乳腺癌中,浸润性癌占92.1%(35/38),0期和Ⅰ期乳腺癌占63.2%(24/38)。结论基于ABUS远程阅片模式的乳腺癌筛查,为解决我国各地医疗资源和医务人员水平不均衡的问题提供了高效、可行的解决路径,实现了优质医疗资源下沉,提高了高质量筛查服务的可及性,并取得了良好的筛查效果,为乳腺癌筛查提供了新的模式选择。

Objective To construct a remote screening network for breast cancer based on automated breast ultrasound(ABUS)and explore the value of ABUS with remote reading for breast cancer screening.Methods We constructed a remote breast cancer screening network including one remote reading center and 48 image-acquisition centers.We recruited women to participate in breast cancer screening at one of these image-acquisition centers from January 2021 to January 2023.The technicians collected the whole breast images using the ABUS.The images were then sent to the reading center through the PVBUS System and interpreted independently by two radiologists using the Breast Imaging Reporting and Data System(BI-RADS).BI-RADS categories 1 and 2 indicate negative screening results,and women diagnosed with these categories were recommended for annual breast ultrasound screening.BI-RADS categories 3,4,and 5 indicate positive results.Women with BI-RADS category 3 lesions were recommended for follow-up examinations every 6 months using ABUS or handheld ultrasound,while those with BI-RADS 4 and 5 lesions were suggested to undergo pathological examinations.Results In our study,we enrolled 10344 women who completed the ABUS screening and were followed up for more than 12 months.After remote reading,6164 women were diagnosed with BI-RADS category 1 and 2626 woman were within BI-RADS category 2.In contrast,1404 women were within BI-RADS category 3,a total of 135 women were within BI-RADS category 4,and 15 women were within BI-RADS category 5.The positive screening rate of ABUS was 15.0%(1554/10344).The ABUS with remote reading had a detection rate of 3.7/1000(38/10344)for breast cancer screening,with a sensitivity of 97.4%(38/39)and a specificity of 85.3%(8789/10305).Among the 38 breast cancer cases detected,92.1%(35/38)were invasive carcinomas,and 63.2%(24/38)were stage 0 orⅠbreast cancers.Conclusions Breast cancer screening based on ABUS with remote reading provided an efficient and feasible solution to the problem of unevenly distributed medical resources and medical staff levels in various regions of China,enabling the decentralization of high-quality medical resources and improving the accessibility of high-quality screening services.It has provided an alternative for breast cancer screening in China.