Back to Trials
NCT03796559NARecruiting

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Endomagnetics Ltd.

Start Date

6/13/2019

Completion Date

5/1/2026

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Magseed Marker

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Breast CancerAxillary Lymph Nodes

Locations

Baylor Medicine

Houston, Texas 77030

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States