RecruitingNot ApplicableNCT05625659

Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts

Comparison of Breast Cancer Screening With Dual-Energy Contrast-Enhanced Spectral Mammography to Digital Breast Tomosynthesis in Women With Dense Breasts (Contrast Mammography Imaging Screening Trial


Sponsor

American College of Radiology

Enrollment

2,032 participants

Start Date

Mar 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The over-arching goal of the Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST) is to determine if dual-energy contrast-enhanced spectral mammography (CESM) can detect more cancers with fewer false positives than digital breast tomosynthesis (DBT) in women with dense breasts. Aim 1: To evaluate the performance of CESM compared to DBT at baseline for breast-cancer screening in women with dense breasts. Aim 2: To evaluate the performance of CESM compared to DBT at the 1-year follow up for breast-cancer screening in women with dense breasts.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two breast cancer screening methods — contrast-enhanced mammography (CESM) and 3D mammography (DBT) — in women with dense breast tissue to see which finds more cancers. You may be eligible if... - You have dense breast tissue (ACR BI-RADS category c or d) on your most recent prior mammogram - You have no current breast symptoms (no lumps, nipple discharge, or focal pain) - You are able to receive IV contrast dye (iohexol) safely - You are not pregnant or breastfeeding - You agree not to get a separate whole-breast ultrasound during the trial period You may NOT be eligible if... - You have breast symptoms or signs of breast disease - You have an allergy to iodinated contrast or a moderate-to-severe allergic history - You are pregnant or could be pregnant (a pregnancy test may be required) - You are breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDual-Energy Contrast-Enhanced Spectral Mammography (CESM)

In addition to their standard, digital breast tomosynthesis mammogram (DBT) performed at their regular screening visits, all participants will also receive a contrast-enhanced spectral mammography (CESM). These same diagnostic tests, both the DBT and CESM, with be repeated at 1 year post study entry for all participants. At year 2 post study entry, all participants will return to their usual breast screening exams and no longer received a CESM.


Locations(11)

University of Alabama, Birmingham

Birmingham, Alabama, United States

Boca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness Institute

Boca Raton, Florida, United States

Lake Medical Imaging

The Villages, Florida, United States

Boston Breast Diagnostic Center

Wellesley Hills, Massachusetts, United States

Henry Ford Health

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Carolina Breast Imaging Specialists

Greenville, North Carolina, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

St. Joseph's Hospital

London, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05625659


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