Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy (SentiNeo2)

February 19, 2026 updated by: Roger Olofsson Bagge, Vastra Gotaland Region

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

459

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Roger Olofsson Bagge, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients planned for preoperative chemotherapy before breast surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Node negative
Clinically node negative before neoadjuvant chemotherapy
Device: Magtrace
Sentinel lymph node tracer and metastatic lymph node clip
Other Names:
  • Magseed
Node positive
Clinically node positive before neoadjuvant chemotherapy
Device: Magtrace
Sentinel lymph node tracer and metastatic lymph node clip
Other Names:
  • Magseed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUGBG-2023002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

ON request. Pseudoanonymised data.

IPD Sharing Time Frame

2 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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