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Safety, Ultrasound Conspicuity, and Migration of Twinkling Markers in Patients With Locally Advanced Breast Cancer
Sponsor: Mayo Clinic
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
15
Start Date
2023-03-21
Completion Date
2027-11-30
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Magnetic Resonance Imaging
Undergo MRI
Mammogram
Undergo a mammogram
Ultrasound
Undergo a breast ultrasound
Ultrasound-Guided Biopsy
Undergo a percutaneous ultrasound-guided breast clip placement
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.
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States