Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

Inclusion Criteria:

Female sex Age 35 years or older Any ethnicity 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 study imaging within four weeks from the date of diagnostic mammography, prior
to breast biopsy (if needed).

Able to provide informed consent Post-menopausal, surgically sterile, or effective birth
control. For women of childbearing potential, negative pregnancy test or has signed
pregnancy test waiver If required by standard of care, eGFR >45 within 48 hours to 6 weeks
of CE-CBBCT exam

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 Contrast Injection:

Allergic to iodinated contrast material Previous non-ionic contrast reaction Any conditions
below regardless of eGFR Renal Disease Chronic renal dysfunction Renal Transplant (or
waiting for a transplant) One kidney or other birth defect Polycystic Kidneys Renal
Tumor/Renal Cancer History of liver failure/cirrhosis/liver transplant/pending liver
transplant Congestive heart failure Multiple myeloma Hyperthyroidism Pheochromocytoma
Sickle Cell Disease Asthma requiring daily use of inhaler

Additional exclusion criteria due to machine limitations Patient's body weight is over the
limit of the scanner table (440 lbs or 200kg)