Actively Recruiting
A Phase 1 Study to Assess Safety and Ultrasound Visibility of an Optimized Twinkling Marker for Imaging Lymph Nodes in Clinically Node-Positive Breast Cancer
Led by Mayo Clinic ยท Updated on 2026-02-12
20
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating an optimized ultrasound twinkling marker to improve the imaging of lymph nodes in patients with clinically node-positive breast cancer. This phase 1 trial aims to assess the visibility and safety of this new marker, which is designed to enhance ultrasound detection compared to standard biopsy clip markers. The study focuses on patients who have biopsy-proven breast cancer involving lymph nodes and addresses the challenge of consistent marker visibility months after placement. Participants will undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node. Additional ultrasound imaging and standard mammography will be performed before starting neoadjuvant systemic therapy (NST). Optional ultrasound imaging during NST may be done if clinically needed. Surgery will then remove the twinkling marker along with the positive lymph node as part of standard care. Throughout the study, participants will have multiple imaging assessments evaluating the marker's visibility and any migration up to the surgery time, typically spanning 6 to 9 months. Safety will be monitored by tracking adverse events during this period. The main outcomes include how well the marker shows up on ultrasound and its position at surgery, helping to guide surgical removal of affected lymph nodes.
CONDITIONS
Brief 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 breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- Surgical management planned by a designated breast surgeon
- Ability to understand and comply with study procedures for the entire study duration
- No contraception required during the study
You will not qualify if you...
- Pregnant patients
- Current drug or alcohol use or dependence interfering with study adherence
- Current or past participation in another clinical trial within a specified timeframe related to this intervention or treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Generally 6 to 9 months
Participants undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node after confirmation of metastatic axillary lymph node involvement. This is followed by additional ultrasound imaging and standard of care mammography prior to starting neoadjuvant systemic therapy (NST). Optional ultrasound imaging may occur during NST as clinically indicated.
Multiple imaging visits before and during NST as clinically indicated
Duration - Up to the time of surgery
Participants undergo surgical removal of the optimized twinkling marker during standard of care surgical resection of the positive lymph node.
1 surgical visit (in-person)
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
B
Breast and Melanoma Surgical Oncology (BSMO) Clinical Research Unit
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here