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NCT03859492 Clinical Trial

Screening CEDM in Intermediate and High-Risk Patient Populations

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03859492
Other study ID # 18-010602
Secondary ID NCI-2022-11058
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date May 31, 2021

Study information
Verified date August 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 461
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Contrast Enhanced Digital Mammography
High-resolution, low-energy, full-field digital mammography (FFDM) image and contrast-enhanced image

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Breast Cancer Number of subjects diagnosed with breast cancer 3 years
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