NCT06610539

PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients

A Prospective Open Label Study of Patient Reported Outcome Measures and Efficacy Following the Use of 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients Undergoing Lumpectomy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 184 (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 in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures.

Detailed description

The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node (SLN) detection rate in patients who have received 1ml Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures utilising BREAST-Q. Baseline assessment using BREAST-Q will performed. A key secondary objective is to demonstrate non-inferiority of sentinel lymph node (SLN) detection rate with Magtrace compared to the American Society of Breast Surgeons (ASBRS) performance standards. All participants will undergo lymph node mapping with Magtrace, and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system, A sentimag count will be recorded for each node removed. After completion of the surgery, at the postoperative visit the presence of Magtrace related discoloration will be assessed by the Investigator. Participants found to have no Magtrace related discoloration will be asked to complete the Post-Op BREAST-Q assessment and return at 12 months post-op for a follow-up visit. Those patients assessed as having the presence of Magtrace related skin discoloration will be asked complete the post-op BREAST-Q and will then undergo assessment of the size and severity of the discoloration. They will then be asked to return at 6, 12, 18 and 24 months for follow-up visits, or until the discoloration has resolved. At each of these visits the BREAST-Q will be completed, and the size and severity assessment will be performed.

Conditions

• Breast Cancer

Timeline

• Start date: 2025-04-22
• Primary completion: 2028-06-01
• Completion: 2028-11-01
• First posted: 2024-09-24
• Last updated: 2026-03-16

Locations

2 sites across 1 country: United States