Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

A Multicenter, Controlled Clinical Trial to Evaluate the Hologic 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system.

The resulting images from the this portion of the study were then randomized into a reader study.

The purpose of this clinical study was to compare the 3-D tomosynthesis system used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone would:

1. Reduce the recall rate And/or
2. Improve ROC area due to improved breast cancer detection and/or improved lesion classification.

Inclusion Criteria:

• Female
• Any ethnic origin
• No contraindication for screening mammography

Exclusion Criteria:

• Significant breast trauma
• Pregnancy
• Lactating
• Breast implants
• Previous breast cancer
• Previous surgical biopsy
• Placement of an internal breast marker
• Unable to understand and or execute written informed consent