CESM ABMR Breast Cancer Screening Trial

NCT ID: NCT03517813

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 256 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2022-12-31

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).

Conditions

Breast Cancer Screening

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Contrast-enhanced Spectral Mammography (CESM)

Intervention Type: DEVICE

Dual energy mammography images obtained after the administration of an intravenous contrast agent

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.

Contrast-enhanced Spectral Mammography (CESM)

Intervention Type: DEVICE

Dual energy mammography images obtained after the administration of an intravenous contrast agent

Interventions

Contrast-enhanced Spectral Mammography (CESM)

Dual energy mammography images obtained after the administration of an intravenous contrast agent

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janie M Lee

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Seattle Cancer Care Alliance

Seattle, Washington, United States

Countries

United States

Other Identifiers

RG3016008

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2021-12488

Identifier Type: REGISTRY

Identifier Source: secondary_id

9745

Identifier Type: -

Identifier Source: org_study_id