Cone Beam Computed Tomography for Breast Imaging

Inclusion criteria

Group I:

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

Group II:

• Are at least 40 years of age of any ethnicity
• Had a routine mammogram, read as BI-RADS® 4 or 5
• Are scheduled for breast biopsy
• Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
• Is able to undergo informed consent.

Group III:

• Are at least 40 years of age of any ethnicity
• Had a routine mammogram, read as BI-RADS® 4 or 5
• Are scheduled for breast biopsy
• Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
• Is able to undergo informed consent.

Exclusion criteria

Group I and Group II:

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

• Tuberculosis
• Severe scoliosis

Group III:

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

• Tuberculosis
• Severe scoliosis
• Allergy or previous reaction to iodinated contrast material
• History of renal dysfunction/kidney disease
• Long standing diabetes mellitus
• Multiple myeloma
• Dehydration
• History of nephrotoxic medication use
• Hyperthyroidism
• Diabetic patients on Metformin
• Pheochromocytoma
• Sickle Cell Disease