Breast Cancer Clinical Trial

Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

Summary

The purpose of this study is to evaluate how well women may adopt a Contrast-enhanced Spectral Mammography (CESM) as their yearly breast screening test compared to the standard 2-D or 3-D mammogram.

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Full Description

Contrast-enhanced spectral mammography (CESM) is an FDA approved tool for breast cancer detection. However, adoption into clinical practice has been slow. In this study, we will explore patient issues related to the use of CESM for breast cancer screening. For this study, 210 women with heterogeneous or dense breast tissue reported on a previous mammogram, will be recruited to undergo a screening Contrast-enhanced Spectral Mammography (CESM). The CESM will serve as the subject's annual screening breast exam for clinical care. A survey will be administered before and after the examination that evaluates the patient experience. Women will not be at high risk for breast cancer (<20% lifetime risk). All abnormal findings will be acted upon independently. Results of the general screening population survey will be compared with those of women who choose to undergo the CESM examination in order to evaluate the influence of age, education, and lifetime risk on decision making about advanced screening.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

• Female

40 to 69 years
Previous normal mammogram (BI-RADS 1 or 2) showing heterogeneous or extremely dense breast tissue within last 24 months
Scheduled for screening mammogram as part of the patient's clinical care

Exclusion Criteria:

• No mammogram within last 24 months

Fatty or scattered fibroglandular tissue on last mammogram
History of allergy to iodinated contrast
History of renal disease or renal function abnormalities
Pregnant women
History of diabetes
History of paraproteinemia syndromes such as multiple myeloma
History of collagen vascular disease
History of vascular disease (coronary artery disease, myocardial infarction, carotid disease, peripheral vascular disease, or known visceral artery disease)
Previously identified as high risk for breast cancer (>20% lifetime risk)
Asthma
Sickle Cell Anemia
Currently on Dialysis

Study is for people with:

Breast Cancer

Estimated Enrollment:

210

Study ID:

NCT04904757

Recruitment Status:

Recruiting

Sponsor:

University of Virginia

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There is 1 Location for this study

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UVA Breast Care Center
Charlottesville Virginia, 22911, United States More Info
Kathy Repich
Contact
434-825-3112
[email protected]

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Study is for people with:

Breast Cancer

Estimated Enrollment:

210

Study ID:

NCT04904757

Recruitment Status:

Recruiting

Sponsor:


University of Virginia

How clear is this clinincal trial information?

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