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NCT Number: NCT06169072

Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sahlgrenska Iniversity Hospital

Gothenburg, 41345, Sweden

Location status: Recruiting

About this study

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

This is a prospective cohort study where all research persons have SLN biopsy using both SPIO and the dual technique. Then the investigators will compare SLN detection rates between Magtrace 0.1 ml and the dual routine technique with radioactive tracer (Technetium99m, Tc99) +/- blue dye.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned for sentinel lymph node biopsy at (or after) breast surgery
  • Signed and dated written informed consent before the start of specific protocol procedures

Exclusion criteria

  • Pregnant or breast-feeding
  • Iron overload disease
  • Known hypersensitivity to iron, dextran compounds or blue dye.
  • Inability to understand given information and give informed consent or undergo study procedures

Treatment and study plan

Superparamagnetic Iron Oxide

Drug

Superparamagnetic iron oxide (SPIO) consists of an iron oxide nanoparticle core and a hydrophilic coating to make it biocompatible and colloidal stable in a suspension. In this study injected intradermally in an ultra-low dose

Other names: Magtrace

Technetium99

Device

Technetium99 +/- blue dye is injected per routine as a comparator and as back up.

Primary outcomes

  1. SLN detection rate for Magtrace 0.1 ml and for dual technique (Tc99 +/- blue dye) measured as per cent of patients where a SLN is identified using either the magnetic or the dual technique.

    Time frame: During the procedure

    percentage

Secondary outcomes

  1. MRI Magtrace artefacts

    Time frame: 3-6, 12 and 24-36 months postoperatively

    Measured as per cent of patients with remaining artefacts evaluated by blinded central review.

  2. Skin staining due to injected Magtrace

    Time frame: 4 weeks, 12, 24 and 36 months postoperatively

    Measured as per cent of patients with remaining brown or blue skin staining and stain size, evaluated by the investigator and the Skin Discoloration Impact Evaluation Questionnaire (SDIEQ)

  3. Rate of device-related AE and SAEs

    Time frame: During the procedure

    Number

  4. Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye)

    Time frame: During the procedure

    Numbers

  5. Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye)

    Time frame: During the procedure

    percentage

Study contacts

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

Fredrik Wärnberg

CONTACT

[email protected]

+4631823931

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer

Acronym: MagSnow2

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Dec 13, 2023
Registry last updated
Jan 26, 2024

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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