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Screening CEDM in Intermediate and High-Risk Patient Populations

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03859492
Collaborator
(none)
461
Enrollment
1
Location
27.5
Actual Duration (Months)
16.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Contrast Enhanced Digital Mammography

Study Design

Study Type:
Observational
Actual Enrollment :
461 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations
Actual Study Start Date :
Feb 15, 2019
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Intermediate or high-risk breast cancer subjects

Subjects with a negative mammogram who are intermediate or high-risk for breast cancer will get supplemental screening with contrast enhanced digital mammography (CEDM)

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Breast Cancer [3 years]

      Number of subjects diagnosed with breast cancer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Bhavika Patel, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bhavika Patel, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03859492
    Other Study ID Numbers:
    • 18-010602
    First Posted:
    Mar 1, 2019
    Last Update Posted:
    Jul 1, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 1, 2021