RecruitingNot Applicable

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

United States2,032 participantsStarted 2023-03-24

Plain-language 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.

Who can participate

Age range45 Years – 74 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. a mammogram less than 11 months prior to study entry.
✕. screening breast ultrasound within 11 months prior to study entry.
✕. breast MRI less than 36 months prior to study entry.
✕. contrast-enhanced spectral mammography less than 36 months prior to study entry.
✕. molecular breast imaging (MBI) less than 36 months prior to study entry.
✕. breast prosthetic implants (silicone or saline).
✕. suspected of being at high-risk for breast cancer, as defined by the ACS breast MR screening recommendations (lifetime risk of ≥20%-25%) unless they are unable to undergo an MRI. (Reference Appendix I)
✕. a history of sickle cell disease.

What they're measuring

Cancer Detection Rate

Timeframe: Year 0

Recall Rate

Timeframe: 1 Year

Trial details

NCT IDNCT05625659

SponsorAmerican College of Radiology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Christopher Comstock, MD

212-746-6000 chc4050@med.cornell.edu

View on ClinicalTrials.gov More Breast Cancer trials