Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
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|ClinicalTrials.gov Identifier: NCT03482557|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: CESM Device: MRI||Not Applicable|
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 are already getting a breast biopsy will have a contrast enhanced mammogram and a breast MRI before the biopsy. The participant's contrast enhanced mammogram and breast MRI images will then be included within a large collection of images. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening|
|Actual Study Start Date :||May 17, 2018|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: CESM VS 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.
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 Name: Contrast Enhanced Spectral Mammography
MRI uses magnets to create a detailed image of the tissues and bones inside of the body
Other Name: Magnetic Resonance Imaging
- Diagnostic accuracy of CESM compared with breast MRI for breast cancer screening [ 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.
- Diagnostic accuracy of CESM compared with abbreviated MRI for breast cancer detection [ Time Frame: 2 years ]We will determine whether CESM is non-inferior to abbreviated breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.
- Diagnostic accuracy of CESM compared with conventional mammography for breast cancer screening [ Time Frame: 2 years ]We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.
- Patient preference for breast MRI versus CESM for breast cancer screening [ Time Frame: 2 years ]We will provide each patient with a survey following completing of the CESM and MRI exams to understand which exam the patients prefer for breast cancer screening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482557
|Contact: Layla Rahimifirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Layla Rahimi 617-667-3118 email@example.com|
|Principal Investigator: Jordana Phillips, MD|
|Principal Investigator:||Jordana Phillips, MD||Beth Israel Deaconess Medical Center|