Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm Full Field Digital Mammography (FFDM) Plus Digital Breast Tomosynthesis (DBT) Versus FFDM Alone in the Detection of Breast Cancer

The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.

This pilot reader study was to determine the following:

1. the radiologist's performance metrics for the two reading modalities, i.e., "FFDM read on the Aspire Bellus workstation" and "FFDM read in conjunction with DBT read on the Aspire Bellus workstation",;
2. the magnitude and direction of differences between performance metrics for the two modalities; and
3. variance components and correlations that would influence samples sizes and case mix for the subsequent pivotal reader study comparing performance metrics between the two modalities.

Inclusion Criteria:

• Female subjects participating in FMSU004A protocol with known clinical status

Exclusion Criteria:

• Subjects with unknown clinical status not participating in FMSU004A protocol.