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

Vastra Gotaland Region

Status and phase: Enrolling; Phase 2

Conditions: Sentinel Lymph Node; Breast Cancer

Treatments: Device: Technetium99; Drug: Superparamagnetic Iron Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT06169072

SUGBG-2022002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Sentinel node detection with 0.1mL SPIO and Technetium99

Other group

Description:

An intradermal injection of SPIO (MagTrace®), according to the pre-specified dose of 0.1mL, will be performed 7 days, up to the day of surgery. The injection should be in the skin over the tumour, or at the border of the areola. All patients will also receive technetium per routine.

Treatment:

Device: Technetium99

Drug: Superparamagnetic Iron Oxide