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NCT Number: NCT04904757

Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

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.

Recruiting

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Key information

Age range

40 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UVA Breast Care Center

Charlottesville, Virginia, 22911, United States

Location status: Recruiting

Location contact

Kathy Repich

CONTACT

[email protected]

434-825-3112

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast-enhanced spectral mammography (CESM)

Device

CESM is a mammogram performed after the injection of IV contrast. 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. Two images are taken almost at the same time during the exam, after the iodine based contrast injection is administered. The first image is comparable to a regular mammogram. The second image shows areas that take up the contrast (enhance) showing increased blood flow. Breast cancers often enhance with contrast due to a greater amount of blood vessels. Non-cancerous lesions can also have greater blood flow.

Primary outcomes

  1. Evaluate the patient experience during a screening CESM

    Time frame: 16 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.

Secondary outcomes

  1. determine if there is an association between the willingness to undergo CESM and age, level of education, and breast cancer related risk factors.

    Time frame: 16months

    We will evaluate differences by age, education, and risk factors as to whether these drive willingness to undergo CESM.

    Data summarization: Binary risk factors will be summarized by frequencies and percentages. Continuous scaled risk factors will be summarized by the mean and standard deviation, the median and interquartile range, and the range of distribution.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy L Repich, RN

CONTACT

[email protected]

4342434540

Matthew M Miller, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM

Acronym: S-CESM

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
May 27, 2021
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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