Clinical Trials

Inclusion 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.

Exclusion Criteria:

• 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 whole breast ultrasound (WBUS) for screening, with either a hand-held ultrasound probe or automated system, within 12 months prior to study enrollment. 
• 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.