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

NCT06169072 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-01-26

No results posted yet for this 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.

Conditions

Interventions

DRUG

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

DEVICE

Technetium99

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

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Fredrik Wärnberg · Sahlgrenska University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-07-01
Completion
2027-07-01

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169072 on ClinicalTrials.gov