Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04904757
Status
Recruiting
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Conditions

  • Mammographic Breast Density
  • Mammography

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 19, 2019
Status verified
Nov 2022
Primary completion
Dec 31, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
210 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UVA Breast Care CenterCharlottesvilleVirginia22911
Kathy Repich
[email protected]
434-825-3112

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By research site
UVA Breast Care Center· Charlottesville, VA

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