Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Other: MRI; Other: CESM

• Registration Number: NCT02275871
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.

Detailed Description

This research study is being done to test how well a contrast enhanced mammogram compares to MRI in screening for breast cancer in people who are at higher risk for developing breast cancer.

Standard screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. For this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). The only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies.

In the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound.

We are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for breast cancer.

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Study Start: 2014-11
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• Women
• Age > or equal to 30 years
• High risk (>20% lifetime risk)
• Has a bilateral mammogram within the last 7 months
• Has had a same day high risk screening MRI

Exclusion Criteria

• Participants who have a known allergy or contraindication to iodinated contrast.
• Participants who have a known allergy to food or medications.
• Participants who have renal insufficiency or failure.
• Participants who are pregnant or breastfeeding.
• Participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI and CESM	MRI	High risk patients will get standard of care screening MRI and study CESM on the same day.
MRI and CESM	CESM	High risk patients will get standard of care screening MRI and study CESM on the same day.

Primary Outcome Measures

Name	Time	Method
Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity	4 years	All CESM and MRI cases will be evaluated for the presence or absence of malignancy and will be coded to reflect this interpretation. Breast imaging-reporting and data system (BIRADS) scores of 1-3 represent the absence of malignancy and BIRADS code of 4-5 represent the presence of malignancy. These cases will be compared to the truth of whether malignancy developed in the patient based on biopsy results and long term clinical follow-up (2 years).

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States