Koning Breast CT for Breast Imaging in China

Non-contrast KBCT

Inclusion criteria

• Females at least 35 years of age of any ethnicity
• Had diagnostic imaging
• Will undergo study imaging no later than two weeks from date of diagnostic mammogram
• Is able to undergo informed consent

Exclusion criteria

• 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

Contrast-enhanced KBCT

Inclusion criteria

• Females at least 35 years of age of any ethnicity
• Had diagnostic imaging and was determined to have biopsy or surgery
• Will undergo study imaging no later than two weeks from date of diagnostic mammogram
• Is able to undergo informed consent

Exclusion criteria

Same as the exclusion criteria as non-contrast KBCT, plus the following:

• Abnormal Glomerular Filtration Rate (GFR)/Blood Urea Nitrogen (BUN) or Creatinine at Pre contrast blood screening
• Previous non-ionic contrast reaction
• History of renal dysfunction/kidney disease
• Diabetes mellitus treated with metformin
• Multiple myeloma
• Dehydration
• History of nephrotoxic medication use
• Hyperthyroidism
• Pheochromocytoma
• Sickle Cell Disease