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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
NameTimeMethod
Breast Cancer3 years

Number of subjects diagnosed with breast cancer

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic in Arizona

🇺🇸

Scottsdale, Arizona, United States

Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States

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