Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RG3016008 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2021-12488 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Asymptomatic women at increased risk of breast cancer referred clinically for high risk screening breast MRI or women with newly diagnosed primary unilateral breast cancer referred for evaluation of extent of disease (EOD) in the index breast and screening of the contralateral breast. All women enrolled on study will complete a clinical breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam. |
| |
| Cohort 2 | Women receiving MRI for any indication and for whom percutaneous biopsy with ultrasound or MRI guidance has been recommended. All women enrolled on study will complete a standard breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced Spectral Mammography (CESM) | Device | Dual energy mammography images obtained after the administration of an intravenous contrast agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal interpretation rate | Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy rate | Biopsy rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 2 years |
| Positive predictive value for biopsy recommendation (PPV2) | Positive predictive value for biopsy recommendation (PPV2) will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Women referred for a clinical breast MRI.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janie M Lee | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Cancer Care Alliance | Seattle | Washington | 98102 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 years |
| Negative predictive value | Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 3 years |
| Cancer detection rate | Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 3 years |
| Sensitivity | Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 2 years |
| Specificity | Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 2 years |