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

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.

• Magnetic Resonance Imaging (Procedure), 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: Undergo MRI
• Mammogram (Procedure): Undergo a mammogram
• Ultrasound (Procedure): Undergo a breast ultrasound
• Ultrasound-Guided Biopsy (Procedure), also known as Ultrasound Guided Biopsy: Undergo a percutaneous ultrasound-guided breast clip 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.

Primary outcomes

• Long-term efficacy of the twinkling marker [through study completion, an average of 4 months]: 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.

Secondary outcomes

• Determination of safety and migration of the twinkling marker [through study completion, an average of 4 months]: The secondary outcome is determination of safety and migration of the Mayo-designed twinkling marker in patients after NST. Clinical notes will be reviewed to assess for any complications related to the twinkling marker during NST. Migration will be determined from surgical and pathology documentation.

Sex: All, ages: 18 Years to any

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

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