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

NCT05625659 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2032

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)

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.

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Breast Cancer Research Foundation

    collaborator OTHER

  • American College of Radiology

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05625659 on ClinicalTrials.gov