Trial Information

To Determine the Impact on Reader Performance, as Defined by the Area Under the Receiver Operating Characteristic Curve, When Automated Breast Ultrasound and a Screening Mammogram Are Combined, Compared to a Screening Mammogram Alone in Asymptomatic Women With >50% Parenchymal Density and a Screening Mammogram Assigned a BI-RADS Assessment Category 1 (Negative) or 2 (Normal With Benign Findings).

The Clinical Retrospective Reader Study is an observational case-controlled, multi-reader
multi-case Receiver Operating Characteristic (ROC) study involving approximately 16
Interpreting Physicians (Readers) and approximately 200 breast screening cases which will be
reviewed and of those, 164 breast screening cases will be included in the primary data
analysis. All primary data analysis cases will consist of screening mammogram and Automated
Breast Ultrasound image readings from the same asymptomatic females with >50% parenchymal
density for whom the screening mammogram was assigned a BI-RADS Assessment Category 1
(negative) or 2 (normal with benign findings).

The Readers will review a total of 200 cases: the Non-Cancer Case Set, the Cancer Case Set,
and additional Control and Supplemental Case Sets. These cases will be randomized during the
reading session so each Reader will review the entire Case Set in a unique order.

The primary Receiver Operating Characteristic analysis will be performed on the Readers'
Likelihood of Malignancy (LOM) ratings from their initial review of the screening mammogram
alone and their final review of the screening mammogram and Automated Breast Ultrasound for
the Non-Cancer Case Set and Cancer Case Set.