Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
Start Date
3/24/2023
Completion Date
7/31/2027
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.
Detailed Description
The Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST), which will be managed by the American College of Radiology (ACR), Center for Research and Innovation (CRI), seeks to determine if dual-energy contrast-enhanced spectral mammography (CESM) screening provides more accurate cancer detection compared to digital breast tomosynthesis (DBT) in women with dense breasts. Year 0 Visit: All women aged 45 to 74 years of age known mammographically dense breasts, as reported on their most recent prior mammogram who are scheduled for a routine annual screening DBT will be offered CESM in addition to DBT. Baseline imaging (Year 0) will be performed within 30 days after participant registration. Standard DBT screening views followed by standard CESM screening views will be performed on the same day and prior to any additional workup. Year 1 Visit (12 Months ±2 Months After Year 0 Imaging): Standard DBT screening views followed by standard CESM screening views will be performed on the same day and prior to any additional workup. Year 2 Visit: Follow-Up - Return for Standard Mammography Screening (12 Months ±2 Months After Year 1 Imaging): The 2-year participant follow-up contact (email, text, or phone calls) should be performed 12 months (±2 months) after the Year 1 imaging to confirm the participant has not been diagnosed with an interval breast cancer. If 2-year imaging has not been scheduled, the 2-year participant follow-up contact should be performed prior to 14 months post year 1 visit. Participants diagnosed with breast cancer in the interval between the Year 1 and Year 2 imaging studies will have no subsequent follow-up and will not undergo the Year 2 study imaging in the scope of the study. The participant will be asked for AEs/SAEs with a non-leading question.
Eligibility Criteria
Age Range: 45 years to 74 years
Interventions
Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)
Conditions
Locations
University of Alabama, Birmingham
Birmingham, Alabama 35233
United States
Boca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness Institute
Boca Raton, Florida 33486
United States
Lake Medical Imaging
The Villages, Florida 32159
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Boston Breast Diagnostic Center
Wellesley Hills, Massachusetts 02481
United States
Henry Ford Health
Detroit, Michigan 48202
United States
Thomas Jefferson University
Sewell, New Jersey 08080
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Carolina Breast Imaging Specialists
Greenville, North Carolina 27834
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Virginia
Charlottesville, Virginia 22911
United States
St. Joseph's Hospital
London, Ontario N6A 4V2
Canada