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Screening CEDM in Intermediate and High-Risk Patient Populations

Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations

NCT03859492•Mayo Clinic

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.

Eligibility

Age

35 - No limit years

Sex

FEMALE

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

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Key Dates

Start Date

February 15, 2019

Primary Completion Date

May 31, 2021

Completion Date

May 31, 2021

Last Updated

August 24, 2023

Enrollment

461

ACTUAL participants

Conditions

Breast Cancer

Interventions

Contrast Enhanced Digital Mammography

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Screening CEDM in Intermediate and High-Risk Patient Populations

Inclusion Criteria

Exclusion Criteria

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