Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: CESM; Device: MRI

Detailed Description

Mammography is the main way to help find breast cancers early so they can be treated. Unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. In these women, breast MRI is also used to help find breast cancers.

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. This is similar to breast MRI.

For this study, participants who had both CEM and MRI evaluating a finding that initiated from a screening exam will be included. Radiologists will compare the images to see if the contrast enhanced mammograms and the breast MRI find the same number of breast cancers. If the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CESM and MRI exam performed within 3 months of one another.
• CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
• CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
• MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted

Exclusion Criteria:

• Imaging sets with implants.
• Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
• Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contrast-Enhanced Spectral Mammography; Each enrolled participant will receive a CESM either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CESM must be performed prior to biopsy.	Device: CESM; Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone; Other Names: Contrast Enhanced Spectral Mammography
Experimental: Breast MRI; Each enrolled participant will receive an MRI exam either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the MRI must be performed prior to biopsy.	Device: MRI; MRI uses magnets to create a detailed image of the tissues and bones inside of the body; Other Names: Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening	We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening	Radiologist readers evaluated CEM and abbreviated MRI in 132 patients, some who had cancer and some who did not. The area under the curve was determine for each reader for each exam type.	2 years
Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening	We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.	2 years

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: GE Healthcare; Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Olga Brook, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; screening; contrast enhanced spectral mammography; breast MRI
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 17-689

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.: No