Breast Cancer Screening
Conditions
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).
Interventions
Dual energy mammography images obtained after the administration of an intravenous contrast agent
Sponsors
GE Healthcare
University of Washington
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal interpretation rate | 2 years | Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Negative predictive value | 3 years | Negative predictive value 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) |
| Sensitivity | 2 years | Sensitivity 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) |
| Cancer detection rate | 3 years | Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) |
Countries
United States
Outcome results
None listed