Breast Cancer Clinical Trial
High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)
Summary
This study is being performed to find out if a new kind of breast imaging (called contrast-media enhanced breast CT or CE-BCT) can help doctors to see the small structures in breast tissue more clearly. This study is also being performed to find out if using the CE-BCT will separate cancers from non-cancers. This is important because 25% to 35% of structures that do not appear to be normal and are removed from the breast (biopsied) for studying under a microscope turn out to be cancer.
Full Description
The breast imaging device that will be used in this study (breast computed tomography or BCT) is not FDA-approved for this use so this is a research study. The machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose.
An x-ray dye will be injected through a needle in the subject's arm before the test. The FDA has approved this dye for other uses, but not for this exam, so the use of the dye is also research.
The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast. It does not compress or squash the breast like a mammogram.
Eligibility Criteria
Inclusion criteria:
who were asymptomatic and 40 years of age or older (typical screening age range) at the time of the screening exam that prompted the recall
who were assigned BI-RADS category 4 or 5 after x-ray based diagnostic work-up such as mammography or digital breast tomosynthesis (DBT)
who have no known adverse reaction to iodinated contrast media
who satisfy University of Arizona (UA) - Banner University Medical Center (BUMC), Department of Medical Imaging policy for administration of iodinated contrast media for computed tomography (CT) imaging, which may include a blood draw for renal function assessment.
Exclusion criteria:
Males,
women less than 40 years old,
women unable to self-consent,
prisoners,
pregnant or lactating women (If premenopausal, urine pregnancy test will be used to determine pregnancy)
women 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;
women who are unable to tolerate study constraints, frail, or unable to cooperate;
women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system;
women 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, and treatment for Hodgkin's disease;
women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram;
women with glomerular filtration rate (GFR) less than 30 mL/min/1.73 m^2 indicative of impaired kidney function,
women with known allergies to contrast media,
women who have received large number of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.
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There is 1 Location for this study
Tucson Arizona, 85724, United States More Info
Principal Investigator
Sub-Investigator
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