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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel node detection with 0.1mL SPIO and Technetium99 | Other | An intradermal injection of SPIO (MagTrace®), according to the pre-specified dose of 0.1mL, will be performed 7 days, up to the day of surgery. The injection should be in the skin over the tumour, or at the border of the areola. All patients will also receive technetium per routine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| MRI Magtrace artefacts | Measured as per cent of patients with remaining artefacts evaluated by blinded central review. | 3-6, 12 and 24-36 months postoperatively |
| Skin staining due to injected Magtrace |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fredrik Wärnberg | Contact | +4631823931 | fredrik.warnberg@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Fredrik Wärnberg | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Iniversity Hospital | Recruiting | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29855858 | Background | Balch CM. Detection of melanoma metastases with the sentinel node biopsy: the legacy of Donald L. Morton, MD (1934-2014). Clin Exp Metastasis. 2018 Aug;35(5-6):425-429. doi: 10.1007/s10585-018-9908-8. Epub 2018 May 31. | |
| 27782005 | Background | Waanders S, Visscher M, Wildeboer RR, Oderkerk TO, Krooshoop HJ, Ten Haken B. A handheld SPIO-based sentinel lymph node mapping device using differential magnetometry. Phys Med Biol. 2016 Nov 21;61(22):8120-8134. doi: 10.1088/0031-9155/61/22/8120. Epub 2016 Oct 26. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 28, 2025 | |
| Reset | Aug 12, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2023 | Nov 18, 2023 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 28, 2025 | Aug 12, 2025 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C065507 | ferumoxides |
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|
| Technetium99 | Device | Technetium99 +/- blue dye is injected per routine as a comparator and as back up. |
|
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)
| 4 weeks, 12, 24 and 36 months postoperatively |
| Rate of device-related AE and SAEs | Number | During the procedure |
| Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye) | Numbers | During the procedure |
| Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye) | percentage | During the procedure |
| 28877348 | Background | Karakatsanis A, Daskalakis K, Stalberg P, Olofsson H, Andersson Y, Eriksson S, Bergkvist L, Warnberg F. Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer. Br J Surg. 2017 Nov;104(12):1675-1685. doi: 10.1002/bjs.10606. Epub 2017 Sep 6. |
| 35000820 | Background | Mirzaei N, Katsarelias D, Zaar P, Jalnefjord O, Johansson I, Leonhardt H, Warnberg F, Olofsson Bagge R. Sentinel lymph node localization and staging with a low-dose of superparamagnetic iron oxide (SPIO) enhanced MRI and magnetometer in patients with cutaneous melanoma of the extremity - The MAGMEN feasibility study. Eur J Surg Oncol. 2022 Feb;48(2):326-332. doi: 10.1016/j.ejso.2021.12.467. Epub 2022 Jan 1. |
| 27117158 | Background | Karakatsanis A, Christiansen PM, Fischer L, Hedin C, Pistioli L, Sund M, Rasmussen NR, Jornsgard H, Tegnelius D, Eriksson S, Daskalakis K, Warnberg F, Markopoulos CJ, Bergkvist L. The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc(99) and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies. Breast Cancer Res Treat. 2016 Jun;157(2):281-294. doi: 10.1007/s10549-016-3809-9. Epub 2016 Apr 27. |
| 33572114 | Background | Hersi AF, Pistiolis L, Dussan Luberth C, Vikhe-Patil E, Nilsson F, Mohammed I, Olofsson Bagge R, Warnberg F, Eriksson S, Karakatsanis A. Optimizing Dose and Timing in Magnetic Tracer Techniques for Sentinel Lymph Node Detection in Early Breast Cancers: The Prospective Multicenter SentiDose Trial. Cancers (Basel). 2021 Feb 9;13(4):693. doi: 10.3390/cancers13040693. |
| D017437 |
| Skin and Connective Tissue Diseases |