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Clinical Trials in Sweden / NCT06169072
Recruiting Phase 2

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

NCT06169072 · tracked via the Priya Life Science Sweden tracker
Sponsor
Vastra Gotaland Region
Phase
Phase 2
Started
2023-01-01
Last updated
2024-01-26

Condition(s) studied

Breast CancerSentinel Lymph Node

Investigational drug(s) / intervention(s)

Superparamagnetic Iron OxideTechnetium99

Superparamagnetic 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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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. — During the procedure
    percentage

Trial sites (1)

FacilityCityRegionStatus
Sahlgrenska Iniversity Hospital Gothenburg Sweden Recruiting

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Other trials for the same condition

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Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients Active, not recruiting
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease Active, not recruiting
Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06169072 on ClinicalTrials.gov ↗ ← All trials in Sweden