RecruitingNot Applicable

Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

United States210 participantsStarted 2019-09-19

Plain-language 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.

Who can participate

Age range

40 Years – 69 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the patient experience during a screening CESM

Timeframe: 16 months

Trial details

NCT IDNCT04904757

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

Contact for this trial

Kathy L Repich, RN

4342434540 klr3b@virginia.edu

View on ClinicalTrials.gov More Mammographic Breast Density trials