NCT03482557

Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 30 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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
DEVICE	MRI	MRI uses magnets to create a detailed image of the tissues and bones inside of the body

Timeline

• Start date: 2018-05-17
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2018-03-29
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study