NCT02275871

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

Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	MRI	High risk screening MRI will be performed as part of the patient's routine care.
OTHER	CESM	After the MRI is complete, the patient will be brought to the mammography department for the contrast enhanced mammogram. The contrast enhanced mammogram will be independently interpreted by two study radiologists (randomly assigned) who are blinded to the MRI. They will then compare to the MRI to determine clinical follow-up. Any finding seen on MRI will be followed according to the MR protocol. Any finding seen on CESM only, will have a diagnostic work-up with mammography and ultrasound. If this work-up is negative, then follow-up CESM exams will be performed. Each patient will be followed for 2 years to determine sensitivity and specificity for both modalities.

Timeline

• Start date: 2014-11-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2014-10-27
• Last updated: 2020-03-16

Locations

1 site across 1 country: United States