RecruitingPhase 2NCT06169072

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

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

Sponsor

Vastra Gotaland Region

Enrollment

220 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Sentinel Lymph Node

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an extremely small dose of Magtrace (an iron-based dye injected to locate sentinel lymph nodes in breast cancer) works just as well as the standard dose. Sentinel lymph node biopsy helps surgeons find out if breast cancer has spread to nearby lymph nodes. **You may be eligible if...** - You are scheduled for a sentinel lymph node biopsy at or after breast surgery - You have signed a consent form **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a condition causing iron overload in the body - You have a known allergy to iron, dextran compounds, or blue dye - You are unable to understand the study information or give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSuperparamagnetic Iron Oxide

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

DEVICETechnetium99

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

Locations(1)

Sahlgrenska Iniversity Hospital

Gothenburg, Sweden

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NCT06169072

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