Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
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 criteria
Qualifiers
Planned for sentinel lymph node biopsy at (or after) breast surgery
Signed and dated written informed consent before the start of specific protocol procedures
Disqualifiers
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
Trial design
Treatments tested in this trial
- Superparamagnetic Iron Oxide
- Technetium99
Treatment groups
220 Participants
are divided into 1 treatment groupSponsors and collaborators
Vastra Gotaland Region
Lead sponsor
Sahlgrenska University Hospital
Sponsor institution
Source ClinicalTrials.gov