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Recruiting NCT06104371

Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magtrace.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Device Magtrace
    Sentinel lymph node tracer and metastatic lymph node clip

Primary outcome measures

  • Sentinel lymph node detection rate [Time frame: Perioperatively]
Secondary outcome measures (2)
  • Number of sentinel lymph nodes detected per tracer [Time frame: Perioperatively]
  • Concordance of nodes per tracer [Time frame: Perioperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Sweden · 1 center
  • Sahlgrenska University Hospital — Gothenburg

Identifiers

NCT: NCT06104371 · SUGBG-2023002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗