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Actively Recruiting

Phase Not Applicable
Age: 45Years - 74Years
FEMALE
Healthy Volunteers
ID05625659

Study Comparing Contrast-Enhanced Spectral Mammography and Digital Breast Tomosynthesis for Breast Cancer Screening in Women With Dense Breasts Aged 45 to 74

Led by American College of Radiology · Updated on 2026-07-31

2032

Participants Needed

13

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

The Contrast-Enhanced Spectral Mammography Imaging Screening Trial CMIST aims to find out if dual-energy contrast-enhanced spectral mammography CESM can detect more breast cancers with fewer false positives than digital breast tomosynthesis DBT in women with dense breasts. The study evaluates these two imaging methods at baseline and after one year to improve breast cancer screening accuracy in women aged 45 to 74 with dense breast tissue. Participants will receive both standard DBT and CESM screenings on the same day at the start of the study and again after one year. At the two-year point, participants will return to their usual mammography screening without CESM. The study involves routine imaging procedures without additional treatments, aiming to compare the diagnostic performance of these imaging techniques. Throughout the study, participants will have baseline and one-year imaging visits, followed by a two-year follow-up contact to confirm no interval breast cancer diagnosis. Researchers will monitor cancer detection rates at baseline and recall rates at one year. Safety questions about adverse events will be asked during follow-up, and participants usual breast cancer screening care will continue after study completion.

CONDITIONS

Brief Title

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

Research Team

C

Christopher Comstock, MD

E

Etta Pisano, MD

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