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Optimized Ultrasound Twinkling Marker for Breast Cancer Lymph Nodes (UTMOST2 Trial)

This study, called the UTMOST2 Trial, is looking at a new way to make lymph nodes with breast cancer easier to see on ultrasound. If you have breast cancer that has spread to your lymph nodes (clinically node-positive breast cancer), you might be able to join. Researchers will place a special "twinkling marker" into the affected lymph node using ultrasound guidance. They want to see how well this marker shows up on ultrasound images over several months, before you have surgery. This is important because these markers help doctors guide surgery. The study aims to enroll 20 women.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 20 participants.
What's involved
You would undergo mammography, ultrasound imaging, and have an optimized twinkling marker placed in your lymph node. You will also have surgical removal of the lymph node as part of your standard care. The twinkling marker's visibility will be checked from baseline up to your final pre-operative imaging, generally 6-9 months.
Compensation
Not stated in the trial record.
Follow-up
The twinkling marker's visibility will be measured up to the final pre-operative imaging before surgery, generally 6-9 months. Its migration will be measured at the time of surgery.

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NCT06999798

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

Recruiting
PHASE1Ages 18+InterventionalDevice feasibility
Mayo Clinic
~20 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Diagnostic MammographyResectionUltrasound ImagingTwinkling Marker Placement

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Conspicuity of the optimized Mayo-developed twinkling marker
Measured over Baseline up to final pre-operative imaging before surgery; generally 6-9 months
+1 more outcome measured

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

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Breast Carcinoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Christine U. Lee, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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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)
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

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

What this trial measures

  • Conspicuity of the optimized Mayo-developed twinkling markerBaseline up to final pre-operative imaging before surgery; generally 6-9 months

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

  • Migration of the optimized Mayo-developed twinkling markerAt time of surgery (baseline)

    Will be determined from surgical and pathology documentation after node resection