From the Department of Radiology, Oslo University Hospital Ullevaal, University of Oslo, Kirkeveien 166, N-0407 Oslo, Norway (P.S., E.B.E., I.N.J., M.K., U.H., M.I., R.G.); Department of Biostatistics, University of Pittsburgh, Pittsburgh, Pa (A.I.B.); Curato Roentgen Institute, Oslo, Norway (U.E.); and Institute of Population-based Cancer Research, the Cancer Registry, Oslo, Norway (S.H.).
Radiology. 2014 Jun;271(3):655-63. doi: 10.1148/radiol.13131391. Epub 2014 Jan 24.
To compare the performance of two versions of reconstructed two-dimensional (2D) images in combination with digital breast tomosynthesis (DBT) versus the performance of standard full-field digital mammography (FFDM) plus DBT.
This trial had ethical committee approval, and all participants gave written informed consent. Examinations (n = 24 901) in women between the ages of 50 and 69 years (mean age, 59.2 years) were interpreted prospectively as part of a screening trial that included independent interpretations of FFDM plus DBT and reconstructed 2D images plus DBT. Reconstructed 2D images do not require radiation exposure. Using analyses for binary data that accounted for correlated interpretations and were adjusted for reader-specific volume, two versions (initial and current) of reconstructed 2D images used during trial periods 1 (from November 22, 2010, to December 21, 2011; 12 631 women) and 2 (from January 20, 2012, to December 19, 2012; 12 270 women) were compared in terms of cancer detection and false-positive rates with the corresponding FFDM plus DBT interpretations.
Cancer detection rates were 8.0, 7.4, 7.8, and 7.7 per 1000 screening examinations for FFDM plus DBT in period 1, initial reconstructed 2D images plus DBT in period 1, FFDM plus DBT in period 2, and current reconstructed 2D images plus DBT in period 2, respectively. False-positive scores were 5.3%, 4.6%, 4.6%, and 4.5%, respectively. Corresponding reader-adjusted paired comparisons of false-positive scores revealed significant differences for period 1 (P = .012) but not for period 2 (ratio = 0.99; 95% confidence interval: 0.88, 1.11; P = .85).
The combination of current reconstructed 2D images and DBT performed comparably to FFDM plus DBT and is adequate for routine clinical use when interpreting screening mammograms.
比较两种版本的重建二维(2D)图像与标准全数字化乳腺摄影(FFDM)+数字乳腺断层摄影(DBT)的性能。
本试验获得了伦理委员会的批准,所有参与者均签署了书面知情同意书。对年龄在 50 岁至 69 岁(平均年龄 59.2 岁)的女性进行了前瞻性检查,这些检查是作为一项筛查试验的一部分进行的,该试验包括 FFDM+DBT 和重建 2D 图像+DBT 的独立解读。重建的 2D 图像不需要辐射暴露。使用针对二元数据的分析,这些分析考虑了相关解释,并针对读者特定的体积进行了调整,在试验期 1(2010 年 11 月 22 日至 2011 年 12 月 21 日;12631 名女性)和 2(2012 年 1 月 20 日至 2012 年 12 月 19 日;12270 名女性)中,使用两种版本(初始和当前)的重建 2D 图像与相应的 FFDM+DBT 解释进行了癌症检出率和假阳性率的比较。
在第 1 期,FFDM+DBT 的癌症检出率为每 1000 次筛查检查 8.0、7.4、7.8 和 7.7 例,第 1 期初始重建 2D 图像+DBT 为 8.0、7.4、7.8 和 7.7 例,第 2 期 FFDM+DBT 为 8.0、7.4、7.8 和 7.7 例,第 2 期当前重建 2D 图像+DBT 为 8.0、7.4、7.8 和 7.7 例。假阳性评分分别为 5.3%、4.6%、4.6%和 4.5%。相应的读者调整配对比较显示,第 1 期有显著差异(P=0.012),但第 2 期无显著差异(比值=0.99;95%置信区间:0.88,1.11;P=0.85)。
当解释筛查性乳房 X 光照片时,当前重建的 2D 图像与 DBT 的组合与 FFDM+DBT 的性能相当,足以满足常规临床应用。