Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Device: CESM
Device: MRI

Registration Number: NCT03482557

Lead Sponsor: Beth Israel Deaconess Medical Center

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 132

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CESM VS MRI	MRI	Each enrolled participant will receive both a CESM and MRI exam prior to the breast biopsy, if they had not been performed already as part of clinical care. MRI: Breast MRI will be performed, if not already performed as part of clinical care. CESM: After the MRI is complete, patients will be brought to the mammography department for the contrast enhanced mammogram. The CESM will only occur if not already performed as part of the patient's clinical care. Biopsy: Patients will then have their biopsy. Any additional findings seen on the CESM or MRI will be worked up also. Reader Study: The CESM and the MRI images will be included in a case set that is ready by 10 study radiologists at a later date, after the biopsy is performed. These radiologists will look at the images to see if CESM and MRI find the same number of breast cancers.
CESM VS MRI	CESM	Each enrolled participant will receive both a CESM and MRI exam prior to the breast biopsy, if they had not been performed already as part of clinical care. MRI: Breast MRI will be performed, if not already performed as part of clinical care. CESM: After the MRI is complete, patients will be brought to the mammography department for the contrast enhanced mammogram. The CESM will only occur if not already performed as part of the patient's clinical care. Biopsy: Patients will then have their biopsy. Any additional findings seen on the CESM or MRI will be worked up also. Reader Study: The CESM and the MRI images will be included in a case set that is ready by 10 study radiologists at a later date, after the biopsy is performed. These radiologists will look at the images to see if CESM and MRI find the same number of breast cancers.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening	2 years	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.
Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening	2 years	We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.