Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
Up to one hundred (100) female patients will be enrolled and consented to participate in the
 study. These women will be enrolled from screening assigned BIRADS 0, patient complaint, or
 referral for second opinion. The enrolled patient will accept CE-CBBCT scans within 4 weeks
 of her diagnostic mammography and before breast biopsy if biopsy is needed. The final
 diagnostic workup outcome of these enrolled patients needs to include at least 30 confirmed
 cancers cases.
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)