Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients
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.
Conditions studied
Breast Cancer, Sentinel Lymph Node
About this study
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.
Interventions
- Drug: Superparamagnetic Iron Oxide — Superparamagnetic iron oxide (SPIO) consists of an iron oxide nanoparticle core and a hydrophilic coating to make it biocompatible and colloidal stable in a suspension. In this study injected intradermally in an ultra-low dose
- Device: Technetium99 — Technetium99 +/- blue dye is injected per routine as a comparator and as back up.
Primary outcomes
- SLN detection rate for Magtrace 0.1 ml and for dual technique (Tc99 +/- blue dye) measured as per cent of patients where a SLN is identified using either the magnetic or the dual technique. (During the procedure)
Eligibility information
Study locations
- Sahlgrenska Iniversity Hospital, Gothenburg, 41345 Sweden
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.