Cone Beam Breast CT for Breast Cancer Screening

Inclusion Criteria:

Screening Group:

Female sex of any ethnicity
Age 40 years or older
Scheduled for a routine screening mammography exam within 4 weeks.

Diagnostic Group:

Female sex of any ethnicity
Age 20 years or older
Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality.
Will undergo diagnostic mammography, prior to breast biopsy (if needed).

Exclusion Criteria:

Pregnancy
Lactation

Unknown pregnancy status AND

has refused pregnancy testing and
has refused to sign a pregnancy test waiver
Women who are unable or unwilling to understand or to provide informed consent
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.

Women who have received radiation treatments to the thorax or breast area 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 Additional exclusion criteria due to machine limitations
Patient's body weight is over the limit of the scanner table (440 lbs. or 200kg)