Patient Experience After Contrast-enhanced Spectral Mammography for Breast Cancer Screening

This study evaluates 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. CESM is used most often when additional information is needed after a standard mammogram. CESM has also been used to determine the extent of a known breast cancer, to screen patients at high risk for developing breast cancer due to a family history or positive cancer genes, and for women with dense breast tissue. This study may help identify women’s attitudes towards CESM as a screening tool.

Inclusion Criteria

Female
40 to 69 years
Previous normal mammogram (Breast Imaging Reporting and Data System [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
If patient is age 60-69 years we will need to confirm that kidney function is normal. We will draw a small volume of blood and check this unless patient has had a lab test showing normal kidney function in the last 30 days as part of standard of care

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04904757.

PRIMARY OBJECTIVE:

I. To evaluate patient attitudes related to the use of CESM as a breast cancer screening test.

OUTLINE:

Patients undergo CESM and complete surveys prior to and after CESM over 5 minutes.

Trial PhaseNo phase specified

Trial TypeNot provided by clinicaltrials.gov

Lead OrganizationUniversity of Virginia Cancer Center

Principal InvestigatorRamapriya Ganti

Primary ID18853
Secondary IDsNCI-2021-08728
ClinicalTrials.gov IDNCT04904757

Patient Experience After Contrast-enhanced Spectral Mammography for Breast Cancer Screening

Inclusion Criteria

Exclusion Criteria

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Patient Experience After Contrast-enhanced Spectral Mammography for Breast Cancer Screening

Description

Eligibility Criteria

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Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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