Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. (MagLocal)

Sahlgrenska University Hospital

Status: Enrolling

Conditions: Breast Conserving Surgery

Treatments: Device: Metallic clip and guide wire; Device: Magseed

Study type: Interventional

Funder types: Other

Identifiers

NCT06463600

SUGBG-2023001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Tumour localisation with Magseed

Experimental group

Description:

Before preoperative chemotherapy a Magseed is inserted in the breast tumour

Treatment:

Device: Magseed

Metallic marker + guide wire

Active Comparator group

Description:

Before preoperative chemotherapy an ordinary metallic clip is inserted in the breast tumour. Before surgery a guide wire is inserted to localise the clip.

Treatment:

Device: Metallic clip and guide wire