The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.

Inclusion Criteria:

• All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below.
• Able to provide informed consent.

Exclusion Criteria:

• Males

• Women less than 40 years old

• Pregnant women

• Lactating women

• Woman who have had bilateral mastectomies

• Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker

• Women who are unable to tolerate study constraints, frail or unable to cooperate

• Women with large breasts that cannot be accommodated within the field of view of the CT system

• Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

  • Treatment for enlarged thymus gland as an infant
  • Irradiation for benign breast conditions, including breast inflammation after giving birth
  • Treatment for Hodgkin's disease

• Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.

• Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  • Tuberculosis
  • Severe scoliosis

Women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam, and who meet the inclusion criteria, are eligible to participate.