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RECRUITING Phase 1

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

NCT06999798 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Ultrasound Imaging
  • PROCEDURE Resection
  • PROCEDURE Diagnostic Mammography
  • DEVICE Twinkling Marker Placement

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester — Rochester

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2025-08-29
Est. Completion 2026-07-30
Phase Phase 1

Sponsor

Mayo Clinic

3,246 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06999798

The ClinicalTrials.gov registry entry for NCT06999798 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions — of which Ultrasound Imaging is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06999798 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06999798 about?

NCT06999798 is a clinical study titled "An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial". 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 canc...

What is the current status of trial NCT06999798?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-08-29. Estimated completion is 2026-07-30.

What conditions does trial NCT06999798 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06999798?

The interventions under investigation include: Ultrasound Imaging (PROCEDURE), Resection (PROCEDURE), Diagnostic Mammography (PROCEDURE), Twinkling Marker Placement (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06999798?

This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06999798 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial