Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients

Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

This is a prospective cohort study where all research persons have SLN biopsy using both SPIO and the dual technique. Then the investigators will compare SLN detection rates between Magtrace 0.1 ml and the dual routine technique with radioactive tracer (Technetium99m, Tc99) +/- blue dye.

Inclusion Criteria:

• Planned for sentinel lymph node biopsy at (or after) breast surgery
• Signed and dated written informed consent before the start of specific protocol procedures

Exclusion Criteria:

• Pregnant or breast-feeding
• Iron overload disease
• Known hypersensitivity to iron, dextran compounds or blue dye.
• Inability to understand given information and give informed consent or undergo study procedures