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

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: Breast Cancer
• Intervention / Treatment: Device: Magtrace

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

• Study Contact: Name: Fredrik AM Warnberg, prof; Phone Number: +46706146251; Email: fredrik.warnberg@vgregion.se
• Study Contact Backup: Name: Kian AM Chin, MD; Phone Number: +46702316011; Email: kian.chin@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Roger Olofsson Bagge, Dr; Phone Number: +46 31 3428207; Email: roger.olofsson.bagge@gu.se
    • Principal Investigator: Roger Olofsson Bagge, Dr

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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

Collaborators and Investigators

• 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

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: neoadjuvant chemotherapy; sentinel lymph node detection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• 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