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

NCT06999798 | Recruiting Phase 1 DMC FDA Device

• 3 other identifiers: 25-001216NCI-2025-03536R01EB033008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Conspicuity of the optimized Mayo-developed twinkling marker

  Assessed by the visibility/conspicuity of the twinkling marker under ultrasound occurring as part of standard of care \[neoadjuvant systemic therapy (NST)\].

  Baseline up to final pre-operative imaging before surgery; generally 6-9 months

• Migration of the optimized Mayo-developed twinkling marker

  Will be determined from surgical and pathology documentation after node resection

  At time of surgery (baseline)

Secondary Outcomes (1)

• Incidence of adverse events (safety of twinkling marker)

  Baseline up to final visit before surgery; generally 6-9 months

Study Arms (1)

Diagnostic (optimized twinkling marker placement, ultrasound)

EXPERIMENTAL

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.

Procedure: Diagnostic Mammography; Procedure: Resection; Procedure: Ultrasound Imaging; Device: Twinkling Marker Placement

Interventions

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.

Also known as: Twinkle Marker, Mayo Twinkle Marker, Biopsy Twinkle Marker, Biopsy Twinkling Marker, Mayo-designed Twinkling Marker

Diagnostic (optimized twinkling marker placement, ultrasound)

Diagnostic Mammography PROCEDURE

Undergo mammography

Also known as: diagnostic mammogram

Diagnostic (optimized twinkling marker placement, ultrasound)

Resection PROCEDURE

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

Also known as: Surgical Resection

Diagnostic (optimized twinkling marker placement, ultrasound)

Ultrasound Imaging PROCEDURE

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

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Diagnostic (optimized twinkling marker placement, ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Patients who are pregnant
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Christine U. Lee, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Breast and Melanoma Surgical Oncology (BSMO) Clinical Research Unit

CONTACT

507-538-4849; BMSORESEARCH@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 31, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)