Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts (NCT05625659) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
United States, Canada2,032 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 range
45 Years – 74 Years
Sex
FEMALE
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.