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

NCT05547347 | Suspended DMC FDA Device

• 2 other identifiers: 22-002857DTP
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determination of safety and migration of the twinkling marker

  through study completion, an average of 4 months

Study Arms (1)

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; Procedure: Mammogram; Procedure: Ultrasound; Procedure: Ultrasound-Guided Biopsy; Device: Twinkle marker

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Observational (twinkle marker placement)

Mammogram PROCEDURE

Undergo a mammogram

Observational (twinkle marker placement)

Ultrasound PROCEDURE

Undergo a breast ultrasound

Observational (twinkle marker placement)

Ultrasound-Guided Biopsy PROCEDURE

Undergo a percutaneous ultrasound-guided breast clip placement

Also known as: Ultrasound Guided Biopsy

Observational (twinkle marker placement)

Twinkle marker DEVICE

Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker on study.

Observational (twinkle marker placement)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Christine U Lee, M.D., Ph.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: March 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)