NCT03796559

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Endomagnetics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Axillary Lymph Nodes

Interventions

Type	Name	Description
DEVICE	Magseed Marker	Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.

Timeline

• Start date: 2019-06-13
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2019-01-08
• Last updated: 2024-09-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study