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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Drug: Superparamagnetic Iron Oxide
* Device: Technetium99


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sentinel node detection with 0.1mL SPIO and Technetium99<br>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. | Drug: Superparamagnetic Iron Oxide<br>* 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<br>* Other names: Magtrace;Device: Technetium99<br>* Technetium99 +/- blue dye is injected per routine as a comparator and as back up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | percentage | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Magtrace artefacts | Measured as per cent of patients with remaining artefacts evaluated by blinded central review. | 3-6, 12 and 24-36 months postoperatively | 
| Skin staining due to injected Magtrace | 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) | 4 weeks, 12, 24 and 36 months postoperatively | 
| Rate of device-related AE and SAEs | Number | During the procedure | 
| Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye) | Numbers | During the procedure | 
| Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye) | percentage | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Sentinel Lymph Node Biopsy