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

Recruiting now · Phase 2

Conditions studied: Breast Cancer, Sentinel Lymph Node

In brief

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.

Key facts

Study ID

NCT06169072

Run by

Vastra Gotaland Region

People needed

220

Starts

2023-01-01

Expected to finish

2027-07-01

Last updated by the study team

2024-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planned for sentinel lymph node biopsy at (or after) breast surgery
• Signed and dated written informed consent before the start of specific protocol procedures

You may not qualify if…

• 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

• Sahlgrenska Iniversity Hospital — Gothenburg, Sweden (enrolling)

Full record on ClinicalTrials.gov

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