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

NCT05547347 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

Principal Investigators

  • Christine U Lee, M.D., Ph.D. · Mayo Clinic in Rochester

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05547347 on ClinicalTrials.gov