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Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening

This study is looking at how well women accept Contrast-enhanced Spectral Mammography (CESM) as their yearly breast cancer screening test. CESM is a special type of mammogram that uses an injected dye (contrast) to get more detailed images. It's already approved by the FDA for detecting breast cancer. This study aims to understand patients' experiences with CESM for screening, especially for women with dense breast tissue. We are recruiting 210 women, aged 40 to 69, who have had a normal mammogram in the past two years showing dense breast tissue. Your participation would involve undergoing a CESM as your annual screening and completing surveys about your experience. The main goal is to see how patients feel about using CESM for routine screening.

Study design
This is an interventional study planning to enroll 210 women. It will compare the experiences of women who choose CESM screening with those of women in the general screening population.
What's involved
You would undergo a Contrast-enhanced Spectral Mammography (CESM) as your annual breast screening exam and complete surveys before and after the examination.
Compensation
Not stated in the trial record.
Follow-up
The patient experience during screening CESM will be evaluated at 16 months.

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NCT04904757

Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

Recruiting
NAAges 40–69InterventionalScreening
University of Virginia
~210 participants
Updated 2022-11-17 on ClinicalTrials.gov
What's tested:Contrast-enhanced spectral mammography (CESM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the patient experience during a screening CESM
Measured over 16 months

Conditions

Mammographic Breast Density
Mammography

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Virginia1

Who to contact

Kathy L Repich, RN
[email protected]
4342434540
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

• 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

What this trial measures

  • Evaluate the patient experience during a screening CESM16 months

    Plan for primary variable analysis: To evaluate the patient experience during a screening CESM to better understand if women find the experience of contrast injection to be too invasive or unpleasant to repeat or recommend to a friend. Data summarization: Pre and post CESM survey responses that are binary or Likert scaled responses will be summarized by frequencies and percentages. Pre and post CESM survey responses that are continuous scaled responses will be summarized by the mean and standard deviation, the median and interquartile range, and the range of distribution.