Efficacy of Tomosynthesis in the BIRADS 3 Population

The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer

There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.

Inclusion Criteria:

GROUP 1

• female of any race and ethnicity
• 35 years or older
• after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
• subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
• female of any race and ethnicity
• 26 years or older
• subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
• subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
• female of any race and ethnicity
• 26 years or older
• subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
• subject will undergo study imaging within 30 days of surveillance imaging

Exclusion Criteria:

• GROUP 1, 2 and 3
• subjects unable or unwilling to participate
• subjects who are unable or unwilling to tolerate compression
• subjects who are pregnant or who think they may be pregnant
• subjects who are breastfeeding