Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Study Overview
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Brief Summary
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The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.

Detailed Description
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This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.

Official Title
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A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-proven Metastases in Breast Cancer Patients

Conditions
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Breast Cancer, Axillary Lymph Nodes

Intervention / Treatment
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* Device: Magseed Marker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older at time of consent Histologically confirmed cT0-4, N1 breast cancer Axillary lymph node metastasis with pathologic confirmation by needle biopsy Clip placed in the sampled axillary lymph node before initiation of chemotherapy Planned for neo-adjuvant chemotherapy prior to surgical resection Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy ECOG performance status 0-2 Exclusion Criteria: Distant metastases Inflammatory breast cancer Prior ipsilateral axillary surgical procedure including SLND or axillary node excision Prior history of breast cancer in the ipsilateral breast History of lymphoma Subject is pregnant Previous radiation to the breast or axilla Pacemaker or other implantable cardiac device in the ipsilateral chest wall

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magseed marker<br>Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC. | Device: Magseed Marker<br>* Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrieval rate of clipped node and Magseed in the excised specimen | The retrieval rate of the clipped node and Magseed in the excised specimen. This is defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects. | Time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of device and serious device-related events | Rates of device-related adverse events and serious device-related adverse events | Up to 42 days post-surgery | 
| Radiologic rated ease of Magseed placement | 5 point Likert scale, very easy = 5, very difficult = 1 | Time of Magseed marker placement | 
| Radiologic placement accuracy | Success rate of seed placement (placement accuracy) | Between completion of NAC time of surgery | 
| Radiologic seed position | Success rate of maintained seed position at the completion of NAC | After completion of NAC | 
| Surgical nodes localized | Number of nodes retrieved within the surgical specimen containing the Magseed | Time of surgery | 
| Ease of surgical localization | 5 point Likert scalevery easy = 5, very difficult = 1 | Time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neo-adjuvant chemotherapy