Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients with Dense Breast Tissue

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 (Breast Imaging Reporting and Data System [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 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 (contrast enhanced spectral mammography [CESM] or contrast-enhanced digital mammography [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 (atypical ductal hyperplasia [ADH], atypical lobular hyperplasia [ALH], lobular carcinoma in situ [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