Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 2. Women Undergoing Diagnostic Mammography

Comparison of the ability of DBT and FFDM to detect breast cancer.

Inclusion Criteria:

• Women ≥18 years or older and has underwent screening mammography and is now referred for diagnostic mammography
• Able and willing to comply with study procedures, and have signed and dated the informed consent form
• 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