Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients — MagSnow2  

Breast Cancer Clinical Trial

Official title: Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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.

This is a prospective cohort study where all research persons have SLN biopsy using both SPIO and the dual technique. Then the investigators will compare SLN detection rates between Magtrace 0.1 ml and the dual routine technique with radioactive tracer (Technetium99m, Tc99) +/- blue dye. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

• NCT number: NCT06169072
• Study type: Interventional
• Source: Vastra Gotaland Region
• Contact: Fredrik Wärnberg
• Phone: +4631823931
• Email: fredrik.warnberg@vgregion.se
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2023
• Completion date: July 1, 2027