Cone Beam CT for Breast Imaging

Normal Group:

Inclusion criteria

• Are at least 40 years of age of any ethnicity
• Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
• Will undergo study imaging no later than six months from date of routine mammogram.
• Is able to undergo informed consent.

Exclusion criteria

• Pregnancy
• Lactation
• Patients 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.
• Patients who are unable to tolerate study constraints.
• Patients 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
• Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
• Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

• Tuberculosis
• Severe scoliosis

Diagnostic Group:

Inclusion criteria

• Women who are at least 40 years of age of any ethnicity
• Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality
• After diagnostic work-up are categorized as BI-RADS® 4 or 5.
• Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
• Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.

Exclusion criteria

• Pregnancy
• Lactation
• Patients who have already undergone biopsy for the index lesion
• Patients who are unable or unwilling to undergo biopsy for the lesion of concern
• Patients with physical limitations that may prohibit the patient from resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
• Patients who are unable to tolerate study constraints.
• Patients 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
• Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
• Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

• Tuberculosis
• Severe scoliosis