Study to Compare Contrast-Enhanced Ultrasound, Contrast-Enhanced Dual Energy Mammography, and Contrast-Enhanced Breast MR for Early Breast Cancer Detection
Tab Title Description
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.
- 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.
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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.
- 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 the study team for the most up-to-date information regarding possible participation.
Publications are currently not available