CESM ABMR Breast Cancer Screening Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 5/9/2018 |
| Start Date: | January 3, 2018 |
| End Date: | January 2020 |
| Contact: | Janie M Lee |
| Email: | b-imaging-research@seattlecca.org |
| Phone: | 206-606-6777 |
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).
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).
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
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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