Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.

Not Applicable

Recruiting

• Conditions: Breast Conserving Surgery
• Interventions: Device: Magseed; Device: Metallic clip and guide wire

• Registration Number: NCT06463600
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.

Detailed Description

The overall aim is to demonstrate that the use of magnetic clips for tumour localisation before preoperative chemotherapy is feasible at breast cancer surgery and histopathological evaluation in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in combination with a magnetic clip in the index lymph node metastasis if targeted axillary surgery is planned.

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-15
• Last Update Submitted: 2024-06-15
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

1. Age above 18 years
2. Planned for preoperative chemotherapy before breast cancer surgery
3. Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique
4. SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed
5. Signed and dated written informed consent before the start of specific protocol procedures

Exclusion Criteria

1. Pregnant or breast-feeding
2. Iron overload disease
3. Known hypersensitivity to iron or dextran compounds
4. Inability to understand given information and give informed consent or undergo study procedures
5. Planned MRI control for tumour response during chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tumour localisation with Magseed	Magseed	Before preoperative chemotherapy a Magseed is inserted in the breast tumour
Metallic marker + guide wire	Metallic clip and guide wire	Before preoperative chemotherapy an ordinary metallic clip is inserted in the breast tumour. Before surgery a guide wire is inserted to localise the clip.

Primary Outcome Measures

Name	Time	Method
Specimen volume	Perioperatively	The surgical specimen is weighed after removal.

Trial Locations

Locations (1)

Sahlgrenska Academy at Gothenburg University; 🇸🇪 Gothenburg, Göteborg, Sweden