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Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening
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).
Age
18 - 100 years
Sex
FEMALE
Healthy Volunteers
Yes
Seattle Cancer Care Alliance
Seattle, Washington, United States
Start Date
January 3, 2018
Primary Completion Date
June 22, 2021
Completion Date
December 31, 2022
Last Updated
January 6, 2023
256
ACTUAL participants
Contrast-enhanced Spectral Mammography (CESM)
DEVICE
Lead Sponsor
University of Washington
Collaborators
NCT06934239
NCT07472036
Data Source & Attribution
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