Cone Beam CT for Breast Imaging: A Pilot Study

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