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

Abstract

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). 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. 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). 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.