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NCT Number: NCT06999798

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 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.

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Key information

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Christine U. Lee, MD, PhD

PRINCIPAL_INVESTIGATOR

Matthew W. Urban, PhD

SUB_INVESTIGATOR

Shelley Fabian

CONTACT

[email protected]

507-538-4849

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Diagnostic Mammography

Procedure

Undergo mammography

Other names: diagnostic mammogram

Resection

Procedure

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

Other names: Surgical Resection

Ultrasound Imaging

Procedure

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

Other names: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

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.

Other names: Twinkle Marker, Mayo Twinkle Marker, Biopsy Twinkle Marker, Biopsy Twinkling Marker, Mayo-designed Twinkling Marker

Primary outcomes

  1. Conspicuity of the optimized Mayo-developed twinkling marker

    Time frame: Baseline 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)].

  2. Migration of the optimized Mayo-developed twinkling marker

    Time frame: At time of surgery (baseline)

    Will be determined from surgical and pathology documentation after node resection

Secondary outcomes

  1. Incidence of adverse events (safety of twinkling marker)

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

    Adverse events (AEs) are defined as any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research. AEs will be assessed as Mild (events require minimal or no treatment and do not interfere with the participant's daily activities); Moderate (events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning); or Severe (Events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating).Of note, the term "severe" does not necessarily equate to "serious".

Study contacts

Contact information is provided by the study sponsor or research team.

Breast and Melanoma Surgical Oncology (BSMO) Clinical Research Unit

CONTACT

[email protected]

507-538-4849

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

A Phase 1 Study in Patients With Clinically Node-Positive Breast Cancer to Assess the Safety, Ultrasound Conspicuity, and Migration of an Optimized Ultrasound Twinkling Marker Observed for Sonographic Targeting (UTMOST2 Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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