MedPath

CESM ABMR Breast Cancer Screening Trial

Completed
Conditions
Breast Cancer Screening
Registration Number
NCT03517813
Lead Sponsor
University of Washington
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
256
Inclusion Criteria
  • Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
  • Women aged ≥18 years at the time of enrollment
  • Referred clinically for breast MRI for any indication
Exclusion Criteria
  • Known allergy or contraindication to iodinated contrast
  • Are currently pregnant based on urine pregnancy test
  • Have breast implants
  • Are lactating

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Abnormal interpretation rate2 years

Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Secondary Outcome Measures
NameTimeMethod
Negative predictive value3 years

Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Cancer detection rate3 years

Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Biopsy rate2 years

Biopsy rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Positive predictive value for biopsy recommendation (PPV2)3 years

Positive predictive value for biopsy recommendation (PPV2) will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Specificity2 years

Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Sensitivity2 years

Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Trial Locations

Locations (1)

Seattle Cancer Care Alliance

🇺🇸

Seattle, Washington, United States

Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.