Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

NCT06104371 — Recruiting, 459 participants, Vastra Gotaland Region

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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

Registry	NCT06104371, acronym SentiNeo2
Status	Recruiting
Study type	Observational
Enrollment	459 (Estimated)
Sponsor	Vastra Gotaland Region (Other gov); collaborators: Uppsala University, Region Västmanland, University Hospital, Linkoeping, Baylor College of Medicine, The University of Hong Kong-Shenzhen Hospital, Royal Marsden NHS Foundation Trust, University of Athens, University College Dublin
Conditions	Breast Cancer
Interventions	Magtrace (Device)
Dates	start 2025-09-01, primary completion 2027-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2023-10-27, last updated 2026-02-23
Locations	1 site in Sweden

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Node negative		Device: Magtrace	Clinically node negative before neoadjuvant chemotherapy
Node positive		Device: Magtrace	Clinically node positive before neoadjuvant chemotherapy

Magtrace (Device), also known as Magseed: Sentinel lymph node tracer and metastatic lymph node clip

+Outcome measures

Primary outcomes

Sentinel lymph node detection rate [Perioperatively]: per patient

Secondary outcomes

Number of sentinel lymph nodes detected per tracer [Perioperatively]: per node
Concordance of nodes per tracer [Perioperatively]: Ratio

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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

+Locations (1)

Facility	City	Country	Status
Sahlgrenska University Hospital	Gothenburg	Sweden	Recruiting