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Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06104371
Acronym
SentiNeo2
Enrollment
459
Registered
2023-10-27
Start date
2025-09-01
Completion date
2028-12-31
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

sentinel lymph node detection, neoadjuvant chemotherapy

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.

Interventions

DEVICEMagtrace

Sentinel lymph node tracer and metastatic lymph node clip

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sentinel lymph node detection ratePerioperativelyper patient

Secondary

MeasureTime frameDescription
Number of sentinel lymph nodes detected per tracerPerioperativelyper node
Concordance of nodes per tracerPerioperativelyRatio

Countries

Sweden

Contacts

CONTACTFredrik AM Warnberg, prof
fredrik.warnberg@vgregion.se+46706146251
CONTACTKian AM Chin, MD
kian.chin@vgregion.se+46702316011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026