PDF(Pubmed)
Abstract：
UNASSIGNED: Women recalled from breast cancer screening receive post-screening work-up in the hospital with conventional breast imaging. The RACER trial aimed to study whether contrast-enhanced mammography (CEM) as primary imaging instead of conventional imaging resulted in more accurate and efficient diagnostic work-up in recalled women.
UNASSIGNED: In this randomised, controlled trial (registered under NL6413/NTR6589) participants were allocated using deterministic minimisation to CEM or conventional imaging as a primary work-up tool in two general and two academic hospitals. Predefined patients\' factors were reason for recall, BI-RADS score, and study centre. Primary outcomes were sensitivity and specificity. Secondary outcomes were the proportion of women needing supplemental examinations, and number of days until diagnosis.
UNASSIGNED: Between April, 2018, and September, 2021, 529 patients recalled from the Dutch screening program were randomised, 265 to conventional imaging and 264 to CEM. Three patients in the control arm had to be excluded from analysis due to a protocol breach. After the entire work-up, sensitivity was 98.0% (95% CI; 92.2-99.7%) in the intervention arm and 97.7% (91.8-99.6%) in the control arm (p = 1.0), and specificity was 75.6% (72.5-76.6%) and 75.4% (72.5-76.4%, p = 1.0), respectively. Based on only primary full-field digital mammography/digital breast tomosynthesis or CEM, final diagnosis was reached in 27.7% (73/264) in the intervention arm and 1.1% (3/262) in the control arm. The frequency of supplemental imaging was significantly higher in the control arm (p < 0.0001). Median time needed to reach final diagnosis was comparable: 1 day (control arm: IQR 0-4; intervention arm: IQR 0-3). Thirteen malignant occult lesions were detected using CEM, versus three using conventional imaging. No serious adverse events occurred.
UNASSIGNED: Diagnostic accuracy of CEM in the work-up of recalled women is comparable with conventional imaging. However, work-up with CEM as primary imaging is a more efficient pathway.
UNASSIGNED: ZonMw (grant number 843001801) and GE Healthcare.
UNASSIGNED: In this randomised, controlled trial (registered under NL6413/NTR6589) participants were allocated using deterministic minimisation to CEM or conventional imaging as a primary work-up tool in two general and two academic hospitals. Predefined patients\' factors were reason for recall, BI-RADS score, and study centre. Primary outcomes were sensitivity and specificity. Secondary outcomes were the proportion of women needing supplemental examinations, and number of days until diagnosis.
UNASSIGNED: Between April, 2018, and September, 2021, 529 patients recalled from the Dutch screening program were randomised, 265 to conventional imaging and 264 to CEM. Three patients in the control arm had to be excluded from analysis due to a protocol breach. After the entire work-up, sensitivity was 98.0% (95% CI; 92.2-99.7%) in the intervention arm and 97.7% (91.8-99.6%) in the control arm (p = 1.0), and specificity was 75.6% (72.5-76.6%) and 75.4% (72.5-76.4%, p = 1.0), respectively. Based on only primary full-field digital mammography/digital breast tomosynthesis or CEM, final diagnosis was reached in 27.7% (73/264) in the intervention arm and 1.1% (3/262) in the control arm. The frequency of supplemental imaging was significantly higher in the control arm (p < 0.0001). Median time needed to reach final diagnosis was comparable: 1 day (control arm: IQR 0-4; intervention arm: IQR 0-3). Thirteen malignant occult lesions were detected using CEM, versus three using conventional imaging. No serious adverse events occurred.
UNASSIGNED: Diagnostic accuracy of CEM in the work-up of recalled women is comparable with conventional imaging. However, work-up with CEM as primary imaging is a more efficient pathway.
UNASSIGNED: ZonMw (grant number 843001801) and GE Healthcare.
摘要：
■从乳腺癌筛查中召回的妇女在医院接受常规乳腺成像的筛查后检查。RACER试验旨在研究对比增强乳房X线照相术（CEM）作为主要成像而不是常规成像是否可以使召回的女性进行更准确，更有效的诊断检查。
■在这个随机的，对照试验(根据NL6413/NTR6589注册)参与者在两家普通医院和两家学术医院中使用确定性最小化进行CEM或常规成像作为主要检查工具进行分配.预定义的患者因素是召回的原因，BI-RADS评分,和学习中心。主要结果是敏感性和特异性。次要结果是需要补充检查的女性比例，以及诊断前的天数。
■四月之间，2018年9月，2021年，从荷兰筛查计划中召回的529名患者被随机分配，265对常规成像和264对CEM。由于违反协议，对照组中的三名患者必须从分析中排除。在整个工作结束后,干预组的灵敏度为98.0％（95％CI;92.2-99.7％），对照组为97.7％（91.8-99.6％）（p=1.0），特异性为75.6%(72.5-76.6%)和75.4%(72.5-76.4%,p=1.0),分别。仅基于初级全视野数字乳房X线摄影/数字乳房断层合成或CEM，最终诊断在干预组27.7%(73/264),对照组1.1%(3/262).辅助成像的频率在对照臂中显著较高(p<0.0001)。达到最终诊断所需的中位时间相当:1天(控制臂:IQR0-4;干预臂:IQR0-3)。使用CEM检测到13个恶性隐匿性病变，而不是使用传统成像的三个。无严重不良事件发生。
■CEM在召回妇女的检查中的诊断准确性与常规成像相当。然而,以CEM为主要影像学检查是一种更有效的途径。
■ZonMw（授权号843001801）和GEHealthcare。
■在这个随机的，对照试验(根据NL6413/NTR6589注册)参与者在两家普通医院和两家学术医院中使用确定性最小化进行CEM或常规成像作为主要检查工具进行分配.预定义的患者因素是召回的原因，BI-RADS评分,和学习中心。主要结果是敏感性和特异性。次要结果是需要补充检查的女性比例，以及诊断前的天数。
■四月之间，2018年9月，2021年，从荷兰筛查计划中召回的529名患者被随机分配，265对常规成像和264对CEM。由于违反协议，对照组中的三名患者必须从分析中排除。在整个工作结束后,干预组的灵敏度为98.0％（95％CI;92.2-99.7％），对照组为97.7％（91.8-99.6％）（p=1.0），特异性为75.6%(72.5-76.6%)和75.4%(72.5-76.4%,p=1.0),分别。仅基于初级全视野数字乳房X线摄影/数字乳房断层合成或CEM，最终诊断在干预组27.7%(73/264),对照组1.1%(3/262).辅助成像的频率在对照臂中显著较高(p<0.0001)。达到最终诊断所需的中位时间相当:1天(控制臂:IQR0-4;干预臂:IQR0-3)。使用CEM检测到13个恶性隐匿性病变，而不是使用传统成像的三个。无严重不良事件发生。
■CEM在召回妇女的检查中的诊断准确性与常规成像相当。然而,以CEM为主要影像学检查是一种更有效的途径。
■ZonMw（授权号843001801）和GEHealthcare。
