Multicenter Hologic Tomosynthesis Study

A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography

The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.

Inclusion Criteria:

• Female
• Any ethnic origin
• No contraindication of routine bilateral mammography

Exclusion Criteria:

• Any contraindications to mammographic screening, including but not limited to:
• Significant existing breast trauma
• Pregnancy
• Lactating
• Previous surgical biopsy
• Previous breast cancer
• Placement of an internal breast marker
• Breast implants
• Unable to understand and execute written informed consent
• Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure