CESM ABMR Breast Cancer Screening Trial

Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer Screening
• Intervention / Treatment: Device: Contrast-enhanced Spectral Mammography (CESM)

• Study Type: Observational
• Enrollment (Actual): 256

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98102
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women referred for a clinical breast MRI.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Contrast-enhanced Spectral Mammography (CESM); 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.	Device: Contrast-enhanced Spectral Mammography (CESM); Dual energy mammography images obtained after the administration of an intravenous contrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormal interpretation rate	Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)	2 years

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Janie M Lee, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 9745; RG3016008 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2021-12488 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes