Actively Recruiting
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
Led by Mayo Clinic · Updated on 2025-09-30
70
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken. Sometimes a lesion or part of the lesion cannot be seen on ultrasound or mammography, and, therefore, a biopsy guided with ultrasound or mammography may not be always be accurate. Studies have shown that high resolution MBI may have potential to improve the detection of some breast tumors. This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI.
CONDITIONS
Official Title
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure
- Previously underwent an MBI study within the last 3 years showing at least one benign breast imaging finding (Part I)
- Signed study-specific informed consent
- Recent conventional breast imaging showing a breast abnormality requiring biopsy or follow-up as per ACR BIRADS 3 or higher (Part II)
You will not qualify if you...
- Pregnant women
- Women currently lactating or who stopped breastfeeding less than 2 months before the study
- Women younger than 18 years
- Women with breast implants in the breast containing the lesion
- Inability to provide informed consent
- Women who had a breast biopsy within the last 3 months (Part II)
- Women scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of MBI-guided biopsy (Part II)
- Patients with contraindications for core biopsy or unwilling to stop anticoagulant medication before the procedure (Part II)
- Women who had breast surgery on the study breast within the past 12 months (Part II)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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