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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
American College of Radiology
Study ID
NCT05625659
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 74 Years
Healthy Volunteers
Accepted

Interventions

  • Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Mar 24, 2023
Status verified
Feb 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
2,032 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: DBT and CESM Diagnostic Imaging in Women with Dense Breasts
    Interventional Diagnostic

Primary Outcome Measure

Cancer Detection Rate [ Time Frame: Year 0 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama, BirminghamBirminghamAlabama35233
Kathryn Zamora, MD
[email protected]
Boca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness InstituteBoca RatonFlorida33486
Kathy Schilling, MD
[email protected]
Lake Medical ImagingThe VillagesFlorida32159-
Boston Breast Diagnostic CenterWellesley HillsMassachusetts02481
Jordana Phillips, MD
Henry Ford HealthDetroitMichigan48202
Sabala Mandava, MD
[email protected]
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Tali Amir, MD
[email protected]
Carolina Breast Imaging SpecialistsGreenvilleNorth Carolina27834
Bruce Schroeder,, MD
[email protected]
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Jason Shames, MD
[email protected]
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Olena Weaver, MD
[email protected]
University of VirginiaCharlottesvilleVirginia22911
Ramapriya Ganti, MD, PhD
[email protected]

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama, Birmingham· Birmingham, ALBoca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness Institute· Boca Raton, FLLake Medical Imaging· The Villages, FLBoston Breast Diagnostic Center· Wellesley Hills, MAHenry Ford Health· Detroit, MIMemorial Sloan Kettering Cancer Center· New York, NY

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