Last reviewed · How we verify

NCT03482557

Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

Completed NA Results posted Last updated 9 January 2025
What this trial tests

NA trial testing CESM in Breast Cancer in 132 participants. Completed in 30 August 2023.

Timeline
17 May 2018
Primary endpoint
30 August 2023
30 August 2023

Quick facts

Lead sponsorBeth Israel Deaconess Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposescreening
Enrollment132
Start date17 May 2018
Primary completion30 August 2023
Estimated completion30 August 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Beth Israel Deaconess Medical Center

Who can join

Adults 30 to 110, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening Primary · 2 years

We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.

GroupValue95% CI
Cancers Identified With CESM0.91.885 – 0.926
Cancers Identified With Screening MRI.910.894 – 0.925
Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening Secondary · 2 years

Radiologist readers evaluated CEM and abbreviated MRI in 132 patients, some who had cancer and some who did not. The area under the curve was determine for each reader for each exam type.

GroupValue95% CI
CESM.906.885 – 0.926
Screening Abbreviated MRI.894.859 – .929
Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening Secondary · 2 years

We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.

GroupValue95% CI
CESM.906.885 – .926
Screening 2D Mammography.788.756 – .820

Sponsor's own description

This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparison of Contrast-enhanced Mammography with MRI Utilizing an Enriched Reader Study: A Breast Cancer Study (CONTRRAST Trial).
    Phillips J, Mehta TS, Portnow LH, Fishman MDC, et al · · 2023 · cited 13× · PMID 37962503 · DOI 10.1148/radiol.230530

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Beth Israel Deaconess Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03482557.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing