CESM ABMR Breast Cancer Screening Trial

Completed

• Conditions: Breast Cancer Screening
• Interventions: Device: Contrast-enhanced Spectral Mammography (CESM)

• 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

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-05-07
• Primary Completion: 2021-06-22
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 256

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Contrast-enhanced Spectral Mammography (CESM)	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	Contrast-enhanced Spectral Mammography (CESM)	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.

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)
Sensitivity	2 years	Sensitivity 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)

Trial Locations

Locations (1)

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States