NCT03859492
Completed
Not Applicable
Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 461
- Locations
- 1
- Primary Endpoint
- Breast Cancer
Overview
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 mammographic screening.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Breast Cancer
Time Frame: 3 years
Number of subjects diagnosed with breast cancer
Secondary Outcomes
No secondary outcomes reported
Investigators
Bhavika Patel
Principal Investigator
Mayo Clinic
Study Sites (1)
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