Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

NCT04904757 | Recruiting DMC FDA Device

• 1 other identifier: IRB#18853
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the patient experience during a screening CESM

  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.

  16 months

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.

  16months

Study Arms (1)

CESM Pre and Post Survey

OTHER

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

Device: Contrast-enhanced spectral mammography (CESM)

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.

CESM Pre and Post Survey

Eligibility Criteria

• Age: 40 Years - 69 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Breast Care Center

Charlottesville, Virginia, 22911, United States

RECRUITING

Central Study Contacts

Kathy L Repich, RN

CONTACT

4342434540; klr3b@virginia.edu

Matthew M Miller, MD

CONTACT

MM5CA@hscmail.mcc.virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiology-Breast Imaging Faculty, Clinical Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: May 27, 2021
• Study Start: September 19, 2019
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)