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

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