Phase 1 Study of an Optimized Ultrasound Twinkling Marker for Imaging Lymph Nodes in Women With Clinically Node-Positive Breast Cancer

What this Trial Is About

Researchers are evaluating an optimized ultrasound twinkling marker designed to improve imaging of lymph nodes in patients with clinically node-positive breast cancer. This phase I trial focuses on the markers performance, including its visibility on ultrasound compared to standard biopsy clips. Ultrasound is preferred for imaging lymph nodes, especially in the armpit, because it is non-ionizing and more comfortable for patients, but current markers are not consistently visible. Participants will undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node. Following placement, patients receive additional ultrasound imaging and standard mammography before starting neoadjuvant systemic therapy. Optional ultrasound imaging may occur during therapy if clinically needed. Surgery then removes the twinkling marker during standard care lymph node resection. During the study, participants will have imaging assessments over 6 to 9 months to monitor marker visibility and migration. Researchers will also track safety by recording any adverse events up to surgery. The main outcomes include the markers ultrasound conspicuity and its position at surgery. The trial is led by Mayo Clinic and will continue through surgical and imaging evaluations until the study ends.

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