Abstract
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 ( ). 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 ( ; ) and right versus left mediolateral oblique (MLO) ( ; ). However, MD measures from the same breast but different views showed significant bias: right CC versus right MLO ( ; ) and left CC versus left MLO ( ; ). Quantra™ demonstrated substantial agreement with the RANZCR synoptic scale on four- and two-category scales ( ; 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 ( ; 0.84 to 0.91) than a four-category scale ( ; 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.
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