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

Phase

N/A

Condition

Carcinoma

Treatment

Mammogram

Twinkle marker

Ultrasound

Clinical Study ID

NCT05547347

22-002857

DTP

NCI-2022-06278

Ages > 18
All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient 18 years or older with breast cancer and biopsy-proven malignant involvementof an axillary lymph node
Surgical management will be determined by the surgeon, who will decide ifpreoperative I-125 seed localization of the positive node is necessary or if theywill retrieve the positive node with intraoperative ultrasound guidance. Duringsurgery, the targeted node, its associated biopsy markers, I-125 seed if placed, andtwinkling marker will be resected. The position of the marker in the lymph node orproximity 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 andMelanoma 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 forthe entire length of the study
No contraception is necessary or required

Exclusion

Exclusion Criteria:

Current drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements
Inability or unwillingness of individual or legal guardian/representative to givewritten informed consent
Current or past participation within a specified timeframe in another clinicaltrial, as warranted by the administration of this intervention

Study Design

Mammogram

March 21, 2023

December 31, 2025

Study 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.

Connect with a study center

Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Site Not Available

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