The primary hypothesis to be tested is:

The detection of breast cancer will be increased with tomosynthesis (3D) imaging

The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.

Inclusion Criteria:

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

Exclusion Criteria:

Potential subjects with any of the following will not be enrolled in the study:

• Any contraindications to mammographic screening, including, but not limited to:

• Significant existing breast trauma

• Under the age of 30 at the time of consent

• Breast Implants

• Prior Surgeries

  • Unable to understand and execute written informed consent
  • Pregnant
  • Lactating

496 participants enrolled overall, but no information available to distinguish study arms:

1. Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown).
2. Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown).

PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.

496 participants enrolled overall, but no information available to distinguish study arms:

1. Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number enrolled in arm is unknown).
2. Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number enrolled in arm is unknown).

PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.