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Radiology. 2015 Nov;277(2):527-37. doi: 10.1148/radiol.2015141827. Epub 2015 Jun 23.

MR Imaging as an Additional Screening Modality for the Detection of Breast Cancer in Women Aged 50-75 Years with Extremely Dense Breasts: The DENSE Trial Study Design.

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From the Julius Center for Health Sciences and Primary Care (M.J.E., M.F.B., P.H.M.P., E.M.M., C.H.v.G.) and Department of Radiology (R.M.P., M.A.A.J.v.d.B., W.P.Th.M.M., W.B.V.), Stratenum 6.131, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom (P.H.M.P.); Department of Radiology, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Medical Center, Nijmegen, the Netherlands (R.M.M., N.K.); Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands (M.D.F.d.J.); Department of Radiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands (R.H.C.B.); Department of Radiology, Hospital Group Twente (ZGT), Almelo and Hengelo, the Netherlands (J.V.); Department of Radiology, VU University Medical Center, Amsterdam, the Netherlands (K.M.D.); Department of Radiology, Maastricht University Medical Center, Maastricht, the Netherlands (M.B.I.L.); Dutch Reference Centre for Screening, Nijmegen, the Netherlands (R.M.P.); and Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands (H.J.d.K.).


Women with extremely dense breasts have an increased risk of breast cancer and lower mammographic tumor detectability. Nevertheless, in most countries, these women are currently screened with mammography only. Magnetic resonance (MR) imaging has the potential to improve breast cancer detection at an early stage because of its higher sensitivity. However, MR imaging is more expensive and is expected to be accompanied by an increase in the number of false-positive results and, possibly, an increase in overdiagnosis. To study the additional value of MR imaging, a randomized controlled trial (RCT) design is needed in which one group undergoes mammography and the other group undergoes mammography and MR imaging. With this design, it is possible to determine the proportion of interval cancers within each study arm. For this to be an effective screening strategy, the additional cancers detected at MR imaging screening must be accompanied by a subsequent reduction in interval cancers. The Dense Tissue and Early Breast Neoplasm Screening, or DENSE, trial is a multicenter RCT performed in the Dutch biennial population-based screening program (subject age range, 50-75 years). The study was approved by the Dutch Minister of Health, Welfare and Sport. In this study, mammographic density is measured by using a fully automated volumetric method. Participants with extremely dense breasts (American College of Radiology breast density category 4) and a negative result at mammography (Breast Imaging Recording and Data System category 1 or 2) are randomly assigned to undergo additional MR imaging (n = 7237) or to be treated according to current practice (n = 28 948). Participants provide written informed consent before the MR imaging examination, which consists of dynamic breast MR imaging with gadolinium-based contrast medium and is intended to be performed for three consecutive screening rounds. The primary outcome is the difference in the proportions of interval cancers between the study arms. Secondary outcomes are the number of MR imaging screening-detected cancers, proportions of false-positive results, diagnostic yield of MR imaging, tumor characteristics, quality of life, and cost effectiveness.

[Indexed for MEDLINE]

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