Status:
COMPLETED
Screening CEDM in Intermediate and High-Risk Patient Populations
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Cancer
Eligibility:
FEMALE
35+ years
Phase:
NA
Brief Summary
This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mam...
Eligibility Criteria
Inclusion
- Women aged 35 and had a negative routine mammogram within 6 months.
- Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).
Exclusion
- Known breast cancer
- Previously had negative MBI or MRI within 12 months of study
- Pregnant or lactating
- Contraindication to intravenous iodinated contrast
- Unable to understand or sign informed consent
- Self-reported signs or symptoms of breast cancer
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT03859492
Start Date
February 15 2019
End Date
May 31 2021
Last Update
August 24 2023
Active Locations (1)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259