Clinical trial NCT06169072: Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients
Official title: Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Sentinel Lymph Node
Keywords: Breast cancer
Sentinel Lymph Node Biopsy
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2023-12-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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 outcomes:
measure: 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.
timeFrame: During the procedure
Secondary outcomes:
measure: MRI Magtrace artefacts
timeFrame: 3-6, 12 and 24-36 months postoperatively
measure: Skin staining due to injected Magtrace
timeFrame: 4 weeks, 12, 24 and 36 months postoperatively
measure: Rate of device-related AE and SAEs
timeFrame: During the procedure
measure: Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye)
timeFrame: During the procedure
measure: Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye)
timeFrame: During the procedure
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska Iniversity Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Fredrik Wärnberg
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.