Status:
COMPLETED
Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
GE Healthcare
Dana-Farber Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-110 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- CESM and MRI exam performed within 3 months of one another.
- CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
- CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
- MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted
Exclusion
- Imaging sets with implants.
- Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
- Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available
Key Trial Info
Start Date :
May 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03482557
Start Date
May 17 2018
End Date
August 30 2023
Last Update
January 9 2025
Active Locations (1)
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1
Beth Israel Deaconess
Boston, Massachusetts, United States, 02215