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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-21

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Mammogram

Intervention Type PROCEDURE

Undergo a mammogram

Ultrasound

Intervention Type PROCEDURE

Undergo a breast ultrasound

Ultrasound-Guided Biopsy

Intervention Type PROCEDURE

Undergo a percutaneous ultrasound-guided breast clip placement

Twinkle marker

Intervention Type DEVICE

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

Interventions

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Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Mammogram

Undergo a mammogram

Intervention Type PROCEDURE

Ultrasound

Undergo a breast ultrasound

Intervention Type PROCEDURE

Ultrasound-Guided Biopsy

Undergo a percutaneous ultrasound-guided breast clip placement

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Other Intervention Names

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Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Ultrasound Guided Biopsy

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No