Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography 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