Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening
Sponsor study identifier
Secondary identifiers
OTHER · Fred Hutch/University of Washington Cancer Consortium
REGISTRY · CTRP (Clinical Trial Reporting Program)
observational
256
1 country
1
Study Start
January 3, 2018
Actual (reported)Primary Completion
June 22, 2021
Actual (reported)Study Completion
December 31, 2022
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 3, 2018
Actual (reported)March 27, 2018
Actual (reported)May 7, 2018
Actual (reported)June 22, 2021
Actual (reported)December 31, 2022
Actual (reported)Abnormal interpretation rate
Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)
2 years
Biopsy rate
2 years
Positive predictive value for biopsy recommendation (PPV2)
3 years
Negative predictive value
3 years
Cancer detection rate
3 years
Sensitivity
2 years
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.
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.
Dual energy mammography images obtained after the administration of an intravenous contrast agent
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women referred for a clinical breast MRI.
Seattle Cancer Care Alliance
Seattle, Washington, 98102, United States
Janie M Lee
Fred Hutch/University of Washington Cancer Consortium
256 participants (actual enrollment reported by the registry).
First Submitted
March 27, 2018
First Posted
May 7, 2018
Study Start
January 3, 2018
Actual (reported)A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
Contact the study team to confirm eligibility.
Primary Completion
June 22, 2021
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
January 6, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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