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
Vastra Gotaland Region
220 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria4
- 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
Interventions
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
Technetium99 +/- blue dye is injected per routine as a comparator and as back up.
Locations(1)
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NCT06169072