Screening CEDM in Intermediate and High-Risk Patient Populations

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Contrast Enhanced Digital Mammography

• 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

Study Timeline

• Study Start: 2019-02-15
• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24

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

Arm && Interventions

Group	Intervention	Description
Intermediate or high-risk breast cancer subjects	Contrast Enhanced Digital Mammography	Subjects with a negative mammogram who are intermediate or high-risk for breast cancer will get supplemental screening with contrast enhanced digital mammography (CEDM)

Primary Outcome Measures

Name	Time	Method
Breast Cancer	3 years	Number of subjects diagnosed with breast cancer

Trial Locations

Locations (1)

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