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Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients

RECRUITINGPhase 2Sponsored by Vastra Gotaland Region
Actively Recruiting
PhasePhase 2
SponsorVastra Gotaland Region
Started2023-01-01
Est. completion2024-07-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06169072

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Breast CancerCancerSentinel Lymph Node

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