CESM ABMR Breast Cancer Screening Trial
- 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
- 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
- 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
Name Time Method Abnormal interpretation rate 2 years Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)
- Secondary Outcome Measures
Name Time Method Negative predictive value 3 years Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Cancer detection rate 3 years Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Biopsy rate 2 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)
Specificity 2 years Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Sensitivity 2 years Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Related Research Topics
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Trial Locations
- Locations (1)
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Seattle Cancer Care Alliance🇺🇸Seattle, Washington, United States