Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis

Inclusion Criteria:

• Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
• Women aged ≥18 years at the time of enrollment;*
• Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
• At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:

AND Referred for screening mammography

Exclusion Criteria:

• Have been screened using any breast imaging technology in <12 months immediately prior to enrollment;
• Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
• Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
• Are currently pregnant as determined per standard clinical practice at the investigational site;
• Present with contraindications to any imaging examination required in the study protocol;
• Have breast implants; OR
• Are lactating.