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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06999798
Phase
PHASE1
Status
Recruiting
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Conditions

  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Locally Advanced Breast Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diagnostic Mammography — PROCEDURE
    Undergo mammography
  • Resection — PROCEDURE
    Undergo surgical resection of the lymph node as part of standard care.
  • Ultrasound Imaging — PROCEDURE
    Undergo ultrasound imaging. Ultrasound images will be evaluated for presence and visibility/conspicuity of the twinkling marker.
  • Twinkling Marker Placement — DEVICE
    Undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node after confirmation of metastatic axillary lymph node involvement.

Study Details

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.

Key Dates

Start date
Aug 29, 2025
Status verified
Feb 2026
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Diagnostic (optimized twinkling marker placement, ultrasound)
    Patients undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node, followed by additional ultrasound imaging and SOC mammography prior to starting NST. Patients also undergo optional ultrasound imaging during NST as clinically indicated. Patients then undergo surgical removal of the optimized twinkling marker during SOC surgical resection of the positive lymph node.

Primary Outcome Measure

Conspicuity of the optimized Mayo-developed twinkling marker [ Time Frame: Baseline up to final pre-operative imaging before surgery; generally 6-9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Shelley Fabian
[email protected]
507-538-4849
Christine U. Lee, MD, PhD (PRINCIPAL_INVESTIGATOR)
Matthew W. Urban, PhD (SUB_INVESTIGATOR)

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