Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

Beth Israel Deaconess Medical Center132 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

132

Conditions

Breast Cancer

Interventions

CESMDEVICE

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

MRIDEVICE

MRI uses magnets to create a detailed image of the tissues and bones inside of the body

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

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