CESM ABMR Breast Cancer Screening Trial

• ClinicalTrials.gov Identifier: NCT03517813
• Recruitment Status: Completed
• First Posted: May 7, 2018
• Last Update Posted: January 6, 2023
• Sponsor: University of Washington
• Collaborator: GE Healthcare
• Information provided by (Responsible Party): University of Washington

Study Description

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).

Condition or disease	Intervention/treatment
Breast Cancer Screening	Device: Contrast-enhanced Spectral Mammography (CESM)

Study Design

• Study Type: Observational
• Actual Enrollment: 256 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening
• Actual Study Start Date: January 3, 2018
• Actual Primary Completion Date: June 22, 2021
• Actual Study Completion Date: December 31, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Abnormal interpretation rate [ Time Frame: 2 years ]
   Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Secondary Outcome Measures :

1. Biopsy rate [ Time Frame: 2 years ]
   Biopsy rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
2. Positive predictive value for biopsy recommendation (PPV2) [ Time Frame: 3 years ]
   Positive predictive value for biopsy recommendation (PPV2) will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
3. Negative predictive value [ Time Frame: 3 years ]
   Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
4. Cancer detection rate [ Time Frame: 3 years ]
   Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
5. Sensitivity [ Time Frame: 2 years ]
   Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
6. Specificity [ Time Frame: 2 years ]
   Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Women referred for a clinical breast MRI.

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

Contacts and Locations

Locations

United States, Washington

Seattle Cancer Care Alliance

Seattle, Washington, United States, 98102

Sponsors and Collaborators

University of Washington

GE Healthcare

Investigators

• Principal Investigator: Janie M Lee; Fred Hutch/University of Washington Cancer Consortium

More Information

• Responsible Party: University of Washington
• ClinicalTrials.gov Identifier: NCT03517813
• 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) )
• First Posted: May 7, 2018
• Last Update Posted: January 6, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases