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SUSPENDED
NCT05547347

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States