CESM ABMR Breast Cancer Screening Trial

Breast Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517813
• Other study ID #: 9745
• Secondary ID: RG3016008NCI-202
• Status: Completed
• Start date: January 3, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: December 31, 2022
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Screening
• Breast Neoplasms

Intervention

Device:
• Contrast-enhanced Spectral Mammography (CESM)
Dual energy mammography images obtained after the administration of an intravenous contrast agent

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal interpretation rate	Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)	2 years
Secondary	Biopsy rate	Biopsy rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)	2 years
Secondary	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
Secondary	Negative predictive value	Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)	3 years
Secondary	Cancer detection rate	Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)	3 years
Secondary	Sensitivity	Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)	2 years
Secondary	Specificity	Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)	2 years