Kregting Lindy, van den Oever Daan, Pennings Lian, Pijnappel Ruud, van Ravesteyn Nicolien, Verschuur Ellen, van Oirsouw Marja, Dunning Loes, 't Mannetje Hans, van Engen Ruben, Bluekens Adriana, Smid-Geirnaerdt Maartje, van Landsveld-Verhoeven Cary, Houssami Nehmat, Sechopoulos Ioannis, Broeders Mireille
Radboud University Medical Center, IQ Health science department, Nijmegen, The Netherlands.
Radboud University Medical Center, Department of Medical Imaging, Nijmegen, The Netherlands.
Eur Radiol. 2025 Jan 9. doi: 10.1007/s00330-024-11324-z.
It is uncertain what the effects of introducing digital breast tomosynthesis (DBT) in the Dutch breast cancer screening programme would be on detection, recall, and interval cancers (ICs), while reading times are expected to increase. Therefore, an investigation into the efficiency and cost-effectiveness of DBT screening while optimising reading is required.
The Screening Tomosynthesis trial with advanced REAding Methods (STREAM) aims to include 17,275 women (age 50-72 years) eligible for breast cancer screening in the Netherlands for two biennial DBT screening rounds to determine the short-, medium-, and long-term effects and acceptability of DBT screening and identify an optimised strategy for reading DBT. The control group will consist of 86,400 women selected from the database of the Dutch breast cancer screening programme screened with digital mammography. The intervention group will undergo DBT examinations only. Four different reading strategies will be evaluated on a subset of first-round screening exams. These four strategies will also be evaluated combined with replacing one of the two readers with AI predictions. The Microsimulation Screening Analysis (MISCAN)-Breast model will be used to estimate the long-term outcomes of DBT screening assuming the best-performing reading method.
The primary outcome measure is the IC and advanced cancer rate at the second round (combined endpoint) in the DBT group compared to the control group. Secondary outcome measures are participation, recall and detection rates, positive predictive value, acceptability, reading method with the best case-based area under the curve and reading time, predicted breast cancer mortality, number of cancers overdiagnosed, and cost-effectiveness.
Question The short-, medium-, and long-term effects of digital breast tomosynthesis (DBT) imaging in the Dutch breast cancer screening programme are unknown, but essential to decide about implementation. Findings This protocol paper describes the primary endpoint of the STREAM trial: the combined interval and advanced cancer detection rate at the second DBT round. Clinical relevance The STREAM trial is a prospective, non-randomised, population-based study in the Dutch breast cancer screening programme, that aims to evaluate the effects and acceptability of two rounds of DBT screening to determine if DBT can enhance the programme's outcomes.
在荷兰乳腺癌筛查项目中引入数字乳腺断层合成（DBT）对癌症检测、召回率和间期癌（IC）的影响尚不确定，而阅片时间预计会增加。因此，需要对DBT筛查的效率和成本效益进行调查，同时优化阅片流程。
采用先进阅片方法的乳腺断层合成筛查试验（STREAM）旨在纳入17275名年龄在50 - 72岁、符合荷兰乳腺癌筛查条件的女性，进行两轮为期两年的DBT筛查，以确定DBT筛查的短期、中期和长期效果及可接受性，并确定一种优化的DBT阅片策略。对照组将由从荷兰乳腺癌筛查项目数据库中选取的86400名接受数字乳腺钼靶筛查的女性组成。干预组仅接受DBT检查。将在第一轮筛查检查的一个子集中评估四种不同的阅片策略。这四种策略还将结合用人工智能预测取代两名阅片者之一进行评估。微模拟筛查分析（MISCAN）-乳腺模型将用于估计假设采用表现最佳的阅片方法时DBT筛查的长期结果。
主要结局指标是DBT组与对照组相比第二轮（综合终点）的间期癌和晚期癌症发生率。次要结局指标包括参与率、召回率和检测率、阳性预测值、可接受性、基于病例的曲线下面积最佳的阅片方法和阅片时间、预测的乳腺癌死亡率、过度诊断的癌症数量以及成本效益。
问题 数字乳腺断层合成（DBT）成像在荷兰乳腺癌筛查项目中的短期、中期和长期效果尚不清楚，但对于决定是否实施至关重要。研究结果 本方案文件描述了STREAM试验的主要终点：第二轮DBT筛查时的间期癌和晚期癌症综合检测率。临床意义 STREAM试验是荷兰乳腺癌筛查项目中的一项前瞻性、非随机、基于人群的研究，旨在评估两轮DBT筛查的效果和可接受性，以确定DBT是否能改善该项目的结果。
