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
- PMID: 26110667
- DOI: 10.1148/radiol.2015141827
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
Abstract
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.
© RSNA, 2015
Similar articles
-
Supplemental Screening for Breast Cancer in Women With Dense Breasts: A Systematic Review for the U.S. Preventive Services Task Force.Ann Intern Med. 2016 Feb 16;164(4):268-78. doi: 10.7326/M15-1789. Epub 2016 Jan 12. Ann Intern Med. 2016. PMID: 26757021 Free PMC article. Review.
-
Benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts.Ann Intern Med. 2015 Feb 3;162(3):157-66. doi: 10.7326/M14-0692. Ann Intern Med. 2015. PMID: 25486550 Free PMC article.
-
Assessment of BI-RADS category 4 lesions detected with screening mammography and screening US: utility of MR imaging.Radiology. 2015 Feb;274(2):343-51. doi: 10.1148/radiol.14140645. Epub 2014 Sep 29. Radiology. 2015. PMID: 25271857
-
The role of magnetic resonance imaging in screening women at high risk of breast cancer.Top Magn Reson Imaging. 2008 Jun;19(3):163-9. doi: 10.1097/RMR.0b013e31818bc994. Top Magn Reson Imaging. 2008. PMID: 18941396 Review.
-
Diagnostic accuracy of mammography, clinical examination, US, and MR imaging in preoperative assessment of breast cancer.Radiology. 2004 Dec;233(3):830-49. doi: 10.1148/radiol.2333031484. Epub 2004 Oct 14. Radiology. 2004. PMID: 15486214
Cited by
-
Re-attendance in supplemental breast MRI screening rounds of the DENSE trial for women with extremely dense breasts.Eur Radiol. 2024 Apr 19. doi: 10.1007/s00330-024-10685-9. Online ahead of print. Eur Radiol. 2024. PMID: 38639912
-
The paradox of MRI for breast cancer screening: high-risk and dense breasts-available evidence and current practice.Insights Imaging. 2024 Mar 27;15(1):96. doi: 10.1186/s13244-024-01653-4. Insights Imaging. 2024. PMID: 38536530 Free PMC article. Review.
-
A scoping review of programme specific mammographic breast density related guidelines and practices within breast screening programmes.Eur J Radiol Open. 2023 Aug 2;11:100510. doi: 10.1016/j.ejro.2023.100510. eCollection 2023 Dec. Eur J Radiol Open. 2023. PMID: 37560166 Free PMC article. Review.
-
Breast MRI Provides New Opportunities to Identify Patients at Higher Risk.Radiology. 2023 Aug;308(2):e231633. doi: 10.1148/radiol.231633. Radiology. 2023. PMID: 37552064 No abstract available.
-
Standardised lesion segmentation for imaging biomarker quantitation: a consensus recommendation from ESR and EORTC.Insights Imaging. 2022 Oct 4;13(1):159. doi: 10.1186/s13244-022-01287-4. Insights Imaging. 2022. PMID: 36194301 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Medical