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Multireader Study on the Diagnostic Accuracy of Ultrafast Breast Magnetic Resonance Imaging for Breast Cancer Screening

van Zelst, Jan C.M., MSc, MD*; Vreemann, Suzan, MSc*; Witt, Hans-Joerg, MSc, PhD; Gubern-Merida, Albert, PhD*; Dorrius, Monique D., MD, PhD; Duvivier, Katya, MD§; Lardenoije-Broker, Susanne, MD*; Lobbes, Marc B.I., MD, PhD; Loo, Claudette, MD, PhD; Veldhuis, Wouter, MD, PhD#; Veltman, Jeroen, MD, PhD**; Drieling, Daniel, MSc, PhD; Karssemeijer, Nico, PhD*; Mann, Ritse M., MD, PhD*

doi: 10.1097/RLI.0000000000000494
Original Articles

Objectives Breast cancer screening using magnetic resonance imaging (MRI) has limited accessibility due to high costs of breast MRI. Ultrafast dynamic contrast-enhanced breast MRI can be acquired within 2 minutes. We aimed to assess whether screening performance of breast radiologist using an ultrafast breast MRI-only screening protocol is as good as performance using a full multiparametric diagnostic MRI protocol (FDP).

Materials and Methods The institutional review board approved this study, and waived the need for informed consent. Between January 2012 and June 2014, 1791 consecutive breast cancer screening examinations from 954 women with a lifetime risk of more than 20% were prospectively collected. All women were scanned using a 3 T protocol interleaving ultrafast breast MRI acquisitions in a full multiparametric diagnostic MRI protocol consisting of standard dynamic contrast-enhanced sequences, diffusion-weighted imaging, and T2-weighted imaging. Subsequently, a case set was created including all biopsied screen-detected lesions in this period (31 malignant and 54 benign) and 116 randomly selected normal cases with more than 2 years of follow-up. Prior examinations were included when available. Seven dedicated breast radiologists read all 201 examinations and 153 available priors once using the FDP and once using ultrafast breast MRI only in 2 counterbalanced and crossed-over reading sessions.

Results For reading the FDP versus ultrafast breast MRI alone, sensitivity was 0.86 (95% confidence interval [CI], 0.81–0.90) versus 0.84 (95% CI, 0.78–0.88) (P = 0.50), specificity was 0.76 (95% CI, 0.74–0.79) versus 0.82 (95% CI, 0.79–0.84) (P = 0.002), positive predictive value was 0.40 (95% CI, 0.36–0.45) versus 0.45 (95% CI, 0.41–0.50) (P = 0.14), and area under the receiver operating characteristics curve was 0.89 (95% CI, 0.82–0.96) versus 0.89 (95% CI, 0.82–0.96) (P = 0.83). Ultrafast breast MRI reading was 22.8% faster than reading FDP (P < 0.001). Interreader agreement is significantly better for ultrafast breast MRI (κ = 0.730; 95% CI, 0.699–0.761) than for the FDP (κ = 0.665; 95% CI, 0.633–0.696).

Conclusions Breast MRI screening using only an ultrafast breast MRI protocol is noninferior to screening with an FDP and may result in significantly higher screening specificity and shorter reading time.

From the *Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, the Netherlands;

MeVis Medical Solutions, Bremen, Germany;

Department of Radiology, University Medical Center, Groningen;

§Department of Radiology, VU University Medical Center, Amsterdam;

Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht;

Department of Radiology, the Netherlands Cancer Institute;

#Department of Radiology, University Medical Center, Utrecht; and

**Department of Radiology, ZGT Medical Center, Almelo, the Netherlands.

Received for publication March 20, 2018; and accepted for publication, after revision, May 3, 2018.

Conflicts of interest and sources of funding: H-J.W. and D.D. are employees of Mevis Medical systems. N.K. reports the following conflicts of interest: personal fees from QView Medical and Screenpoint Medical; shareholder in Volpara Solutions, QView Medical, and Screenpoint Medical. R.M.M. reports the following conflicts of interest: Grants from Siemens Healthineers, Medtronic, Seno Medical, IDS, Bayer Healthcare, and Micrima Medical; scientific advisor to Screenpoint medical and Transonic Imaging.

This work was supported by the European Union’s Seventh Framework Programme FP7 (grant agreement number 306088) and the Netherlands Organisation for Health Research and Development (grant agreement number 90514524).

Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.investigativeradiology.com).

Correspondence to: Ritse M. Mann, MD, PhD, Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Internal Route 766, Geert Grooteplein 10, 6525GA Nijmegen, the Netherlands. E-mail: Ritse.mann@radboudumc.nl; Jan C.M. van Zelst, MSc, MD, Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Internal Route 766, Geert Grooteplein 10, 6525GA Nijmegen, the Netherlands. E-mail: jan.vanzelst@radboudumc.nl.

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