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

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

NCT ID: NCT05547347

Condition: Anatomic Stage III Breast Cancer AJCC V8
Locally Advanced Breast Carcinoma
Resectable Breast Carcinoma

Conditions: Official terms:
Carcinoma
Breast Neoplasms

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo MRI
Arm group label: Observational (twinkle marker placement)

Other name: Magnetic Resonance Imaging Scan

Other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

Other name: MR

Other name: MR Imaging

Other name: MRI

Other name: MRI Scan

Other name: NMR Imaging

Other name: NMRI

Other name: Nuclear Magnetic Resonance Imaging

Intervention type: Procedure
Intervention name: Mammogram
Description: Undergo a mammogram
Arm group label: Observational (twinkle marker placement)

Intervention type: Procedure
Intervention name: Ultrasound
Description: Undergo a breast ultrasound
Arm group label: Observational (twinkle marker placement)

Intervention type: Procedure
Intervention name: Ultrasound-Guided Biopsy
Description: Undergo a percutaneous ultrasound-guided breast clip placement
Arm group label: Observational (twinkle marker placement)

Other name: Ultrasound Guided Biopsy

Intervention type: Device
Intervention name: Twinkle marker
Description: Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker on study.
Arm group label: Observational (twinkle marker placement)

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.

Detailed description: PRIMARY OBJECTIVE: I. To show that the biologically inert, Food and Drug Administration (FDA)-approved material that comprises the Mayo-developed twinkling marker (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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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 Dr. Mara Piltin, who will decide if preoperative I-125 seed localization of the positive node is necessary or if she 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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Start date: March 21, 2023

Completion date: December 2025

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05547347
https://www.mayo.edu/research/clinical-trials