Actively Recruiting
An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial
Led by Mayo Clinic · Updated on 2026-02-12
20
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies the performance, including ultrasound visibility, of an optimized ultrasound twinkling marker in imaging lymph nodes in patients with clinically node-positive breast cancer. In patients with biopsy-proven breast cancer, biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are critical for guiding surgical management many months after the marker is placed. For breast radiologists and breast surgeons, there is a need for simple, consistent visibility of biopsy markers by ultrasound, particularly several months after marker placement. Ultrasound is the imaging method of choice, particularly for lymph nodes in the armpit (axilla). Ultrasound is non-ionizing and is more comfortable for patients compared to mammography. However, ultrasound visibility of these markers is challenging and inconsistent, with ultrasound failing to detect the marker approximately 25% of the time. The Mayo-designed investigational biopsy marker takes advantage of an ultrasound phenomenon called twinkling artifact. The Mayo-designed optimized ultrasound twinkling marker may work better than standard biopsy clip marker in imaging lymph nodes in patients with clinically node-positive breast cancer.
CONDITIONS
Official Title
An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years or older with biopsy-proven malignant involvement of an axillary lymph node
- Surgical management will be decided by the surgeon, who may use preoperative iodine-125 seed localization or intraoperative ultrasound guidance to retrieve the positive node
- Surgery will be performed by a surgeon in the Division of Breast and Melanoma Surgical Oncology
- Patients must understand and comply with study procedures for the entire study duration
- No contraception is necessary or required
You will not qualify if you...
- Patients who are pregnant
- Current drug or alcohol use or dependence that may interfere with study adherence, per investigator opinion
- Current or recent participation in another clinical trial involving this intervention
AI-Screening
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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
B
Breast and Melanoma Surgical Oncology (BSMO) Clinical Research Unit
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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