J Breast Cancer.  2021 Apr;24(2):218-228. 10.4048/jbc.2021.24.e19.

Diffusion-Weighted Magnetic Resonance Imaging for Breast Cancer Screening in High-Risk Women: Design and Imaging Protocol of a Prospective Multicenter Study in Korea

Affiliations
  • 1Department of Radiology and Research Institute of Radiology, Asan Medical Center, Seoul, Korea
  • 2Department of Radiology, Seoul National University Hospital, Seoul, Korea
  • 3Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Seoul, Korea
  • 4Department of Radiology, Seoul St. Mary's Hospital, Seoul, Korea
  • 5Department of Radiology, Seoul National University Bundang Hospital, Seoul, Korea
  • 6Department of Radiology, Ajou University Medical Center, Suwon, Korea
  • 7Department of Radiology and Center for Imaging Science, Samsung Medical Center, Seoul, Korea
  • 8Department of Radiology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea
  • 9Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea

Abstract

Purpose
Interest in unenhanced magnetic resonance imaging (MRI) screening for breast cancer is growing due to concerns about gadolinium deposition in the brain and the high cost of contrast-enhanced MRI. The purpose of this report is to describe the protocol of the Diffusion-Weighted Magnetic Resonance Imaging Screening Trial (DWIST), which is a prospective, multicenter, intraindividual comparative cohort study designed to compare the performance of mammography, ultrasonography, dynamic contrast-enhanced (DCE) MRI, and diffusion-weighted (DW) MRI screening in women at high risk of developing breast cancer.
Methods
A total of 890 women with BRCA mutation or family history of breast cancer and lifetime risk ≥ 20% are enrolled. The participants undergo 2 annual breast screenings with digital mammography, ultrasonography, DCE MRI, and DW MRI at 3.0 T. Images are independently interpreted by trained radiologists. The reference standard is a combination of pathology and 12-month follow-up. Each image modality and their combination will be compared in terms of sensitivity, specificity, accuracy, positive predictive value, rate of invasive cancer detection, abnormal interpretation rate, and characteristics of detected cancers. The first participant was enrolled in April 2019. At the time of manuscript submission, 5 academic medical centers in South Korea are actively enrolling eligible women and a total of 235 women have undergone the first round of screening. Completion of enrollment is expected in 2022 and the results of the study are expected to be published in 2026. Discussion: DWIST is the first prospective multicenter study to compare the performance of DW MRI and conventional imaging modalities for breast cancer screening in high-risk women. DWIST is currently in the patient enrollment phase.

Keyword

Breast neoplasms; Clinical trial; Magnetic resonance imaging; Screening
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