Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients
Recruiting
Phase 2
Interventional Study
Breast Cancer
Sentinel Lymph Node
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 220 (estimated)
- Sponsor
- Vastra Gotaland Region · Government
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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.
Trial Locations
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Eligibility Criteria
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…
Contacts