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

• Status: Recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vastra Gotaland Region

Criteria

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