NCT06999798View on ClinicalTrials.gov

An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 29, 2025

Primary Completion Date

July 30, 2026

Study Completion Date

July 30, 2026

Conditions
Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Locally Advanced Breast Carcinoma
Interventions
PROCEDURE

Diagnostic Mammography

Undergo mammography

PROCEDURE

Resection

Undergo surgical resection of the lymph node as part of standard care.

PROCEDURE

Ultrasound Imaging

Undergo ultrasound imaging. Ultrasound images will be evaluated for presence and visibility/conspicuity of the twinkling marker.

DEVICE

Twinkling Marker Placement

Undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node after confirmation of metastatic axillary lymph node involvement.

Trial Locations (1)

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

Mayo Clinic
All Listed Sponsors
collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

lead

Mayo Clinic

OTHER

NCT06999798 - An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial | Biotech Hunter | Biotech Hunter