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Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients
Sponsor: Vastra Gotaland Region
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.
Official title: Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2023-01-01
Completion Date
2027-07-01
Last Updated
2024-01-26
Healthy Volunteers
No
Conditions
Interventions
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
Technetium99
Technetium99 +/- blue dye is injected per routine as a comparator and as back up.
Locations (1)
Sahlgrenska Iniversity Hospital
Gothenburg, Sweden