NCT03517813

CESM ABMR Breast Cancer Screening Trial

Completed Last updated 6 January 2023

What this trial tests

trial testing Contrast-enhanced Spectral Mammography (CESM) in Breast Cancer Screening in 256 participants. Completed in 31 December 2022.

Timeline

3 January 2018

Primary endpoint
22 June 2021

31 December 2022

Quick facts

Lead sponsor	University of Washington
Status	Completed
Study type	OBSERVATIONAL
Enrollment	256
Start date	3 January 2018
Primary completion	22 June 2021
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Contrast-enhanced Spectral Mammography (CESM)

Conditions studied

• Breast Cancer Screening — all drugs for Breast Cancer Screening →

Sponsor

University of Washington

Who can join

Adults 18 to 100, female only, with Breast Cancer Screening. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy.

Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3).

Secondary Aims:

1. Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities.
2. Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnostic accuracy of contrast-enhanced spectral mammography for breast lesions: A systematic review and meta-analysis.
   Suter MB, Pesapane F, Agazzi GM, Gagliardi T, et al · · 2020 · cited 47× · PMID 32540554 · DOI 10.1016/j.breast.2020.06.005
2. Comparative Performance of Contrast-enhanced Mammography, Abbreviated Breast MRI, and Standard Breast MRI for Breast Cancer Screening.
   Lawson MB, Partridge SC, Hippe DS, Rahbar H, et al · · 2023 · cited 29× · PMID 37581498 · DOI 10.1148/radiol.230576