Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

Study Overview
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Brief Summary
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Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identification.

Detailed Description
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This is an interventional single arm study. The aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six moths later. The investigators also want to see if they can find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. The hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemotherapy are the true sentinel lymph nodes. Furthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. This is a well known method but it has not been done in combination with the magnetic tracer. We will show that this is feasible. All patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallel. The magnetic clip is also used at several sites in Sweden today.

Official Title
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Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using Magtrace, (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients. SentiNeo 2.0

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Magtrace


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients 18 years of age or older. Patients with breast cancer planned to undergo NACT with planned sentinel lymph node dissection (SLND), or targeted axillary lymph node dissection (TAD), in conjunction with the breast surgery after NACT. Exclusion Criteria: Intolerance / hypersensitivity to iron or dextran compounds or SPIO. Patients who are required to undergo MRI to evaluate tumour response. Pregnancy or breast feedin.g Patients with an iron overload disease. Patient deprived of liberty or under guardianship. Inability to understand given information and give informed consent or undergo study procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Node negative<br>Clinically node negative before neoadjuvant chemotherapy | Device: Magtrace<br>* Sentinel lymph node tracer and metastatic lymph node clip<br>* Other names: Magseed;|
| Node positive<br>Clinically node positive before neoadjuvant chemotherapy | Device: Magtrace<br>* Sentinel lymph node tracer and metastatic lymph node clip<br>* Other names: Magseed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel lymph node detection rate | per patient | Perioperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sentinel lymph nodes detected per tracer | per node | Perioperatively | 
| Concordance of nodes per tracer | Ratio | Perioperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sentinel lymph node detection, neoadjuvant chemotherapy