Heywang-Köbrunner Sylvia, Jaensch Alexander, Hacker Astrid, Wulz-Horber Sabina, Mertelmeier Thomas, Hölzel Dieter
Em. Head of IBE Institute of Biomathematics and Epidemiology, National Reference Centre Mammography Munich, Munich, Germany.
Em. Head of IBE Institute of Biomathematics and Epidemiology, Brustdiagnostik München, Munich, Germany.
Breast Care (Basel). 2017 May;12(2):92-97. doi: 10.1159/000456649. Epub 2017 Apr 20.
The purpose of this study was to countercheck the equivalence of single-view digital breast tomosynthesis (DBT) or DBT with additional views (DBT+AV) compared to traditional standard assessment by additional views (AV) in patients with a screen-detected abnormality.
Patients with a screen-detected abnormality were consecutively invited to obtain 1 single-view wide-angle DBT in addition to the indicated AV. The study was approved by the local ethics committee and by the Federal Office for Radiation Protection.
This study is based on 311 lesions in 285 patients with a follow-up of > 2 years and/or biopsy. Counting BI-RADS 0 and 3 as positive calls, the sensitivity/specificity of DBT+AV versus DBT only versus AV only were 96.4/54.3%, 96.4/56.6%, and 90.9/42.2%, respectively. The specificities and BI-RADS classifications differed significantly (p < 0.01). AV appeared unnecessary in 88.8% of the cases.
DBT appeared to be at least equivalent to AV for assessing indeterminate screen-detected lesions and could replace AV for most lesions. To obtain the extra information appears possible without increasing the overall radiation dose. Subsequent blinded reader studies are ongoing.
本研究的目的是在筛查发现异常的患者中，对比单视角数字乳腺断层合成（DBT）或附加视角的DBT（DBT+AV）与传统附加视角（AV）标准评估的等效性。
连续邀请筛查发现异常的患者，除进行指定的AV检查外，再进行1次单视角广角DBT检查。本研究获得了当地伦理委员会和联邦辐射防护办公室的批准。
本研究基于285例患者的311个病灶，随访时间超过2年和/或进行了活检。将BI-RADS 0类和3类计为阳性结果，DBT+AV、仅DBT、仅AV的敏感性/特异性分别为96.4/54.3%、96.4/56.6%、90.9/42.2%。特异性和BI-RADS分类存在显著差异（p<0.01）。在88.8%的病例中，AV似乎没有必要。
在评估筛查发现的不确定病灶方面，DBT似乎至少与AV等效，并且对于大多数病灶可以取代AV。在不增加总体辐射剂量的情况下，似乎有可能获得额外信息。后续的盲法阅片研究正在进行中。
