Purpose: This technology evaluation study assesses the limits of agreement between the mammographic density (MD) measurement of Quantra™ from different breasts and mammographic views and its agreement with the Royal Australian and New Zealand College of Radiologists (RANZCR) synoptic scale.
Approach: MD of 800 women was assessed by Quantra™ and seven radiologists using the RANZCR synoptic scale. Bland–Altman analysis was used to assess the limits of agreement between Quantra™ MD measures from both breasts and mammographic views. The agreement between Quantra™ and the RANZCR synoptic scale was assessed using weighted kappa (Kw). The receiver operating characteristics area under the curve (AUC) was used to assess the performance of Quantra™ in reproducing RANZCR MD ratings.
Results: There was no significant bias in the mean MD of Quantra™ from both breasts: left versus right craniocaudal (CC) views (B = − 0.14; p = 0.36) and right versus left mediolateral oblique (MLO) (B = − 0.021; p = 0.18). However, MD measures from the same breast but different views showed significant bias: right CC versus right MLO (B = 0.064; p < 0.0001) and left CC versus left MLO (B = 0.56; p < 0.0001). Quantra™ demonstrated substantial agreement with the RANZCR synoptic scale on four- and two-category scales (Kw = 0.62; 0.59 to 0.66 and 0.76; 0.72 to 0.81, respectively). Quantra™ better reproduced the RANZCR synoptic scale on a two-category scale (AUC = 0.88; 0.84 to 0.91) than a four-category scale (AUC = 0.62; 0.58 to 0.67 to 0.78; 0.74 to 0.82).
Conclusions: Quantra™ reproduces MD classification using the RANZCR synoptic scale on a two-category scale and should help in identification of women with dense breasts who may need adjunctive imaging for early detection of breast cancer.