Image Quality Assessment for Screening and Diagnostic Mammography

Inclusion criteria

• Are women aged 40 years or older (≥40 years old);
• Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
• Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
• Are able to walk without assistive devices;
• Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and
• Are willing to provide written informed consent to participate.

Exclusion criteria

• Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
• Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
• Are currently lactating;
• Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
• If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).