Mayo Designed Soft Tissue Ultrasound-Detectable Marker

Study Overview
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Brief Summary
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Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.

Detailed Description
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Nonrandomized clinical trial to evaluate the Mayo-designed marker for ultrasound conspicuity at the time of preoperative ultrasound-guided localization. Study participants are breast cancer patients with pathology-proven metastatic axillary lymph nodes. Per standard of care, a biopsy marker will have already been associated with the positive lymph node. 10 such patients scheduled for surgery at Mayo Clinic Rochester, MN with Dr. James Jakub will be enrolled. Preoperative radioactive seed localization will proceed as usual, but the marker will be additionally loaded with the seed into the needle using standard protocol. Before surgery, ultrasound will be performed to evaluate the marker.

Official Title
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A Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer

Conditions
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Breast Neoplasm Female, Ultrasound Therapy; Complications

Intervention / Treatment
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* Device: Research Marker


Participation Criteria
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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 involves preoperative radioactive seed localization of a previously identified positive axillary lymph node Surgery will be performed by Dr. James Jakub at Mayo Clinic Rochester, MN Radioactive seed localization of an axillary lymph node. No contraception is necessary or required. English speaking Exclusion Criteria: Scheduled for only radioactive seed localizations in the breast (as opposed to axilla) Are pregnant; although the twinkling marker is made of material widely used in orthopedic procedures, and hence, has an excellent safety profile, the investigators want to exclude the population of pregnant patients in this phase 0 clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Marking cN+ nodes<br>These patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed. | Device: Research Marker<br>* The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound detectability | Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization. | Time of placement to surgical resection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conspicuity compared to conventional biopsy markers and radioactive seeds | To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds. | Time of placement to surgical resection. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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axillary lymph node, biopsy clip, biopsy marker, ultrasound