Breast Cancer Clinical Trial
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
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.
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
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
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