Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Patient is a consenting female age 40-75 years.
- Patient is scheduled for routine screening DBT.
- Patient is asymptomatic for breast disease.
- Patient had heterogeneously dense or extremely dense breasts on most recent prior mammography examination (BI-RADS c or d) within 24 months of enrollment.
- Patient is able to participate fully in all aspects of the study (completing study visits and study data collection).
- Patient understands and signs the study informed consent.
- Patient anticipates being able to return one year after study enrollment to complete the second round of screening.
- Patient is currently pregnant or plans to become pregnant during the course of the study.
- Patient is currently lactating.
- Patient has had a prior MBI.
- Patient has had a prior WBUS, with either a hand-held ultrasound probe or automated system.A prior diagnostic breast ultrasound is not an exclusion criterion.
- Patient has had a prior breast MRI.
- Patient has had a prior contrast-enhanced mammogram (CESM or CEDM).
- Patient is concurrently participating in any other breast imaging research studies that involve undergoing additional breast imaging tests beyond routine screening with mammography, including but not limited to contrast-enhanced mammography, WBUS, MBI, or contrast-enhanced breast MRI.
- Patient has had a breast biopsy within 3 months prior to study enrollment.
- Patient has had breast surgery within 12 months prior to study enrollment.
- Patient is currently undergoing treatment for breast cancer or planning surgery for a high-risk breast lesion (ADH, ALH, LCIS, papilloma, radial scar).
- Patient is currently taking a chemoprevention agent for breast cancer risk reduction or osteoporosis prevention (tamoxifen, raloxifene, anastrazole, letrozole, exemestane).
- Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence.