Health TrialsbyHealthPanel

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

ConditionsBreast CancerSentinel Lymph Node
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Planned for sentinel lymph node biopsy at (or after) breast surgery

Signed and dated written informed consent before the start of specific protocol procedures

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

  • Technetium99

    Device

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

Treatment groups

220 Participants
are divided into 1 treatment group
Group A: Sentinel node detection with 0.1mL SPIO and Technetium99Other 2 interventions

Trial outcomes

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.

percentage

Time frame
During the procedure

Secondary outcomes

1

MRI Magtrace artefacts

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

Time frame
3-6, 12 and 24-36 months postoperatively
2

Skin staining due to injected Magtrace

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)

Time frame
4 weeks, 12, 24 and 36 months postoperatively
3

Rate of device-related AE and SAEs

Number

Time frame
During the procedure
4

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

Numbers

Time frame
During the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Sahlgrenska University Hospital

Sponsor institution

Source ClinicalTrials.gov
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