Breast Cancer, Sentinel Lymph Node
Conditions
Keywords
Breast cancer, Sentinel Lymph Node Biopsy
Brief 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.
Detailed description
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.
Interventions
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.
Sponsors
Vastra Gotaland Region
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI Magtrace artefacts | 3-6, 12 and 24-36 months postoperatively | Measured as per cent of patients with remaining artefacts evaluated by blinded central review. |
| Skin staining due to injected Magtrace | 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) |
| Rate of device-related AE and SAEs | During the procedure | Number |
| Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye) | During the procedure | Numbers |
| Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye) | During the procedure | percentage |
Countries
Sweden
Contacts
Primary ContactFredrik Wärnberg
Outcome results
None listed