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NCT Number: NCT06104371

Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location status: Recruiting

Location contact

Roger Olofsson Bagge, Dr

CONTACT

[email protected]

+46 31 3428207

Roger Olofsson Bagge, Dr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magtrace

Device

Sentinel lymph node tracer and metastatic lymph node clip

Other names: Magseed

Primary outcomes

  1. Sentinel lymph node detection rate

    Time frame: Perioperatively

    per patient

Secondary outcomes

  1. Number of sentinel lymph nodes detected per tracer

    Time frame: Perioperatively

    per node

  2. Concordance of nodes per tracer

    Time frame: Perioperatively

    Ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Fredrik AM Warnberg, prof

CONTACT

[email protected]

+46706146251

Kian AM Chin, MD

CONTACT

[email protected]

+46702316011

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Baylor College of Medicine
  • Region Västmanland
  • Royal Marsden NHS Foundation Trust
  • The University of Hong Kong-Shenzhen Hospital
  • University College Dublin
  • University Hospital, Linkoeping
  • University of Athens
  • Uppsala University

Registry information

Official study title

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

Acronym: SentiNeo2

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 27, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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