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

Phase 2

Recruiting

• Conditions: Sentinel Lymph Node; Breast Cancer
• Interventions: Drug: Superparamagnetic Iron Oxide; Device: Technetium99

• Registration Number: NCT06169072
• Lead Sponsor: Vastra Gotaland Region

Brief 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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-11-18
• Study First Submitted QC: 2023-12-10
• Study First Posted: 2023-12-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel node detection with 0.1mL SPIO and Technetium99	Technetium99	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.
Sentinel node detection with 0.1mL SPIO and Technetium99	Superparamagnetic Iron Oxide	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.

Primary Outcome Measures

Name	Time	Method
SLN detection rate for Magtrace 0.1 ml and for dual technique (Tc99 +/- blue dye) measured as per cent of patients where a SLN is identified using either the magnetic or the dual technique.	During the procedure	percentage

Secondary Outcome Measures

Name	Time	Method
MRI Magtrace artefacts	3-6, 12 and 24-36 months postoperatively	Measured as per cent of patients with remaining artefacts evaluated by blinded central review.
Skin staining due to injected Magtrace	4 weeks, 12, 24 and 36 months postoperatively	Measured as per cent of patients with remaining brown or blue skin staining and stain size, evaluated by the investigator and the Skin Discoloration Impact Evaluation Questionnaire (SDIEQ)
Rate of device-related AE and SAEs	During the procedure	Number
Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye)	During the procedure	Numbers
Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye)	During the procedure	percentage

Trial Locations

Locations (1)

Sahlgrenska Iniversity Hospital; 🇸🇪 Gothenburg, Sweden