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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magseed marker | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magseed Marker | Device | Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matt Womack, PhD | Contact | +447851247439 | mwomack@endomag.com |
| Name | Affiliation | Role |
|---|---|---|
| Abigail Caudle, MD, MS | MD Anderson Cancer Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| D017437 |
| Skin and Connective Tissue Diseases |