Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT). (UBCT)

Inclusion Criteria:

For the screening cohort, the inclusion criteria are, women:

• (1) who were 40 years of age or older (typical screening age range), and,
• (2) who were asymptomatic, and,
• (3) who underwent or scheduled to undergo a standard-of-care 2-view bilateral digital breast tomosynthesis screening exam.

For the diagnostic cohort, the inclusion criteria are, women:

• (1) who were 40 years of age or older, and,
• (2) who underwent a standard-of-care 2-view bilateral digital breast tomosynthesis exam, and,
• (3) who were assigned BI-RADS category 4 or 5 after diagnostic work-up and are scheduled for biopsy.

Exclusion Criteria:

• Males
• Women less than 40 years old
• pregnant or lactating women
• women with physical limitations (e.g., kyphosis) that may prohibit UBCT exam
• women who have received radiation treatments to the thorax
• women who have participated in a prior breast clinical trial that gave additional radiation dose
• women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as tuberculosis, and severe scoliosis.