A Pilot Study - Comparison of Two Hologic 3D Mammography Systems

A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems

Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.

A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.

Inclusion Criteria:

• Female, any ethnic origin
• No contraindication for diagnostic mammography

Exclusion Criteria:

• Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
• Under 30 years of age at the time of consent
• Unable to understand and execute written informed consent