NCT05547347

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)

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Locally Advanced Breast Carcinoma
• Resectable Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Mammogram	Undergo a mammogram
PROCEDURE	Ultrasound	Undergo a breast ultrasound
PROCEDURE	Ultrasound-Guided Biopsy	Undergo a percutaneous ultrasound-guided breast clip placement
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.

Timeline

• Start date: 2023-03-21
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-09-21
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study