Status:
RECRUITING
An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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....
Eligibility Criteria
Inclusion
- Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- Surgical management will be determined by the surgeon, who will decide if preoperative Iodine (I)-125 seed localization of the positive node is necessary or if they will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and optimized twinkling marker will be resected. The position of the marker in the lymph node or proximity to the node will be noted from the surgical and pathology documentation
- Surgery will be performed by one of the surgeons in the Division of Breast and Melanoma Surgical Oncology (Doctor \[Dr.\] Judy Boughey, Dr. Amy Degnim, Dr. Tina Hieken, Dr. Jeffrey Johnson, Dr. Mary Mrdutt, Dr. Shon Black, Dr. Mara Piltin)
- Patients must be able to understand the study procedures and comply with them for the entire length of the study
- No contraception is necessary or required
Exclusion
- Pregnancy
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention
Key Trial Info
Start Date :
August 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06999798
Start Date
August 29 2025
End Date
July 30 2026
Last Update
November 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905