Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Device: Magtrace

• Registration Number: NCT06104371
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Study Start: 2024-12-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Node negative	Magtrace	Clinically node negative before neoadjuvant chemotherapy
Node positive	Magtrace	Clinically node positive before neoadjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
Sentinel lymph node detection rate	Perioperatively	per patient

Secondary Outcome Measures

Name	Time	Method
Number of sentinel lymph nodes detected per tracer	Perioperatively	per node
Concordance of nodes per tracer	Perioperatively	Ratio

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden