Recruiting

CESM

Sponsor:

University of Virginia

Code:

NCT04904757

Conditions

Mammographic Breast Density

Mammography

Eligibility Criteria

Sex: Female

Age: 40 - 69

Healthy Volunteers: Accepted

Interventions

Contrast-enhanced spectral mammography (CESM)

Study Details

Brief 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.

Conditions

Mammographic Breast Density

Mammography

Study ID

NCT04904757

Start date

Sep 19, 2019

Status verified date

Nov, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 69

Healthy Volunteers: Accepted

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 Design

Enrollment

210 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: CESM Pre and Post Survey

Subject will be asked to complete a questionnaire that will ask you about your general attitude toward Contrast-Enhanced Spectral Mammography (CESM). Questions will include:

  • Thoughts regarding risk of breast cancer
  • Concerns regarding contrast procedures such as the CESM
  • Past mammogram/breast imaging experience

Interventions

Contrast-enhanced spectral mammography (CESM)

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 outcome measure

  • Evaluate the patient experience during a screening CESM [ Time Frame: 16 months ]

Central Contacts and Locations

Central contacts

Kathy L Repich, RN

4342434540klr3b@virginia.edu

Matthew M Miller, MD

MM5CA@hscmail.mcc.virginia.edu

Locations

UVA Breast Care Center

Recruiting

Charlottesville, Virginia, United States, 22911

Contacts

Kathy Repich

434-825-3112klr3b@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Nov 17, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2022-11-17.