Safety, Ultrasound Conspicuity, and Migration of Twinkling Markers in Patients With Locally Advanced Breast Cancer

A Phase 1 Study in Patients With Clinically Node-Positive Breast Cancer to Assess the Safety, Ultrasound Conspicuity, and Migration of an Ultrasound Twinkling Marker Obeservedfor Sonographic Targeting (UTMOST TRIAL)

This phase I study assesses the safety, ultrasound visibility (conspicuity), and movement from normal position (migration) of the twinkling marker in patients with breast cancer that has spread to the axillary lymph nodes (locally advanced) who will be undergoing neoadjuvant systemic therapy and surgery. Biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are needed to help guide breast cancer surgery. Twinkling markers are designed to have the same size and shape of conventional biopsy markers, but are made of a radio-opaque material that assists with localization of the marker. The twinkling marker may make it more easily seen with ultrasound at the time of breast cancer surgery as compared to conventional biopsy markers.

Study Overview

• Status: Suspended
• Conditions: Anatomic Stage III Breast Cancer AJCC v8; Locally Advanced Breast Carcinoma; Resectable Breast Carcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Mammogram; Procedure: Ultrasound; Procedure: Ultrasound-Guided Biopsy; Device: Twinkle marker

Detailed Description

PRIMARY OBJECTIVE:

I. To show that the biologically inert, Food and Drug Administration (FDA)-approved material that comprises the Mayo-developed twinkling marker, either pre-made and sterilized or made immediately before placement, (Patent Application Title: Non-Metallic Ultrasound-Detectable Markers Patent Application No.: 62/903,078, Application Type: Provisional) remains conspicuous under ultrasound after neoadjuvant systemic therapy in patients with clinically node-positive breast cancer.

SECONDARY OBJECTIVE:

I. To evaluate the safety and migration of the Mayo-designed twinkling marker in patients during neoadjuvant systemic therapy (NST).

OUTLINE:

Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker throughout the trial. Patients undergo a breast ultrasound during screening, on study, and as clinically indicated. Patient also undergoes a mammogram on study and as clinically indicated as well as a magnetic resonance imaging (MRI) as clinically indicated.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Locally advanced breast cancer patients undergoing neoadjuvant systemic therapy and surgery with Dr. Piltin at Mayo Clinic.

Description

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 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 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 (Dr. Judy Boughey, Dr. Amy Degnim, Dr. Tina Hieken, Dr. Jeffrey Johnson, Dr. Mary Mrdutt, Dr. Dalliah Black, Dr. Mara Piltin)
• 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:

• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent
• Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (twinkle marker placement); Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker throughout the trial. Patients undergo a breast ultrasound during screening, on study, and as clinically indicated. Patient also undergoes a mammogram on study and as clinically indicated as well as a MRI as clinically indicated.

Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Procedure: Mammogram; Undergo a mammogram; Procedure: Ultrasound; Undergo a breast ultrasound; Procedure: Ultrasound-Guided Biopsy; Undergo a percutaneous ultrasound-guided breast clip placement; Other Names: Ultrasound Guided Biopsy; Device: Twinkle marker; Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker on study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term efficacy of the twinkling marker	The primary outcome is information on the long-term efficacy of the twinkling marker in humans placed in the lymph nodes of patients undergoing neoadjuvant systemic therapy (NST) for breast cancer. The data will explore the presence/absence of the twinkling artifact associated with the twinkling marker under ultrasound.	through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of safety and migration of the twinkling marker	The secondary outcome is determination of safety and migration of the Mayo-designed twinkling marker in patients after NST. Clinical notes will be reviewed to assess for any complications related to the twinkling marker during NST. Migration will be determined from surgical and pathology documentation.	through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Christine U Lee, M.D., Ph.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Breast Diseases; Carcinoma; Breast Neoplasms; Investigative Techniques; Physical Phenomena; Chemistry Techniques, Analytical; Spectrum Analysis; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; Magnetic Resonance Spectroscopy; High-Energy Shock Waves
• Other Study ID Numbers: 22-002857 (Mayo Clinic in Rochester); DTP (Other Identifier: Mayo Clinic Radiology)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No