Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

NCT ID: NCT04904757

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2023-06-30

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.

Detailed Description

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.

Conditions

Mammographic Breast Density; Mammography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Contrast-enhanced spectral mammography (CESM)

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Matthew Miller, MD PhD

Radiology-Breast Imaging Faculty, Clinical Assistant Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UVA Breast Care Center

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kathy L Repich, RN

Role: CONTACT

klr3b@virginia.edu

4342434540

Matthew M Miller, MD

Role: CONTACT

MM5CA@hscmail.mcc.virginia.edu

Facility Contacts

Kathy Repich

Role: primary

klr3b@virginia.edu

434-825-3112

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB#18853

Identifier Type: -

Identifier Source: org_study_id