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

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

The investigators are doing this study to find out if a new kind of breast imaging (called upright dedicated breast CT or UBCT) can help doctors to see the small structures in breast tissue more clearly in 3-D and without overlap.

The breast imaging device that will be used in this study (UBCT) is not FDA-approved, so this is a research study. The machine has been designed to remove mammography-like breast compression and use radiation dose comparable to mammography. The breast CT device will take multiple x-ray pictures of the subjects breast in approximately 20 seconds and create a 3-D image of the breast. It does not compress or squish the breast like a mammogram.

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.