Study to Compare Contrast-Enhanced Ultrasound, Contrast-Enhanced Dual Energy Mammography, and Contrast-Enhanced Breast MR for Early Breast Cancer Detection

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-003544
    NCT ID: NCT03954015
    Sponsor Protocol Number: 18-003544

About this study

The purpose of this study is to determine whether contrast-enhanced ultrasound (CEUS) can be used in diagnostic evaluation of breast lesions that cannot be seen using contrast-enhanced MRI (CEMR) and contrast- enhanced dual energy mammography (CEDM).   If so, patients can undergo US guided biopsy which is more comfortable for patients and more cost effective.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Patients, greater than 30 years of age.
  • In good general health as evidenced by medical history.
  • BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy.

Exclusion Criteria:

  • Patients who are less than 30 years of age.
  • Have known or suspected cardiac shunts.
  • Have history of hypersensitive allergic reactions to any imaging contrast agents.
  • Pregnant (a urine pregnancy test will be given at no cost to the patient).
  • Are nursing babies.
  • Poor renal function.
  • Are unwilling or unable (such as having a pacemaker) to undergo a CEMR.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Katrina Glazebrook, M.B., Ch.B.

Open for enrollment

Contact information:

Kathryn Stern

(507)284-4269

Stern.Kathryn@mayo.edu

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions