Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography

To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.

Inclusion Criteria:

• Women ≥18 years or older for screening mammography
• Able and willing to comply with study procedures, and have signed and dated the informed consent form
• The subject is surgically sterile or postmenopausal

Exclusion Criteria:

• Pregnant or trying to become pregnant
• Has signs or symptoms of breast cancer
• Has been previously included in this study
• Has breast implants
• Has a history of breast cancer and is in active treatment
• Has breasts too large to be adequately positioned for the DBT examination