Screening CEDM in Intermediate and High-Risk Patient Populations
Not Applicable
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT03859492
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 461
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Breast Cancer 3 years Number of subjects diagnosed with breast cancer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic in Arizona🇺🇸Scottsdale, Arizona, United States