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

Last updated: January 25, 2024
Sponsor: Vastra Gotaland Region
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

Superparamagnetic Iron Oxide

Technetium99

Clinical Study ID

NCT06169072
SUGBG-2022002
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 studyprocedures

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Superparamagnetic Iron Oxide
Phase: 2
Study Start date:
January 01, 2023
Estimated Completion Date:
July 01, 2027

Study 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.

Connect with a study center

  • Sahlgrenska Iniversity Hospital

    Gothenburg, 41345
    Sweden

    Active - Recruiting

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