Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients
Recruiting · NCT06169072 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Superparamagnetic Iron OxideTechnetium99
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Sahlgrenska Iniversity Hospital - Gothenburg, Sweden