NCT06169072

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer
• Sentinel Lymph Node

Interventions

Type	Name	Description
DRUG	Superparamagnetic Iron Oxide	Superparamagnetic iron oxide (SPIO) consists of an iron oxide nanoparticle core and a hydrophilic coating to make it biocompatible and colloidal stable in a suspension. In this study injected intradermally in an ultra-low dose
DEVICE	Technetium99	Technetium99 +/- blue dye is injected per routine as a comparator and as back up.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-07-01
• Completion: 2027-07-01
• First posted: 2023-12-13
• Last updated: 2024-01-26

Locations

1 site across 1 country: Sweden