Beth Israel Deaconess
Boston, Massachusetts, 02215, United States
NCT Number: NCT03482557
This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening
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Notify Me30 year–110 year
Female
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Contrast Enhanced Spectral Mammography
MRI uses magnets to create a detailed image of the tissues and bones inside of the body
Other names: Magnetic Resonance Imaging
Time frame: 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.
Time frame: 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.
Time frame: 2 years
We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.
Beth Israel Deaconess Medical Center
Other
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