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

Официальное название

Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: During the procedure]

Вторичные конечные точки (5)

• MRI Magtrace artefacts [Срок оценки: 3-6, 12 and 24-36 months postoperatively]
• Skin staining due to injected Magtrace [Срок оценки: 4 weeks, 12, 24 and 36 months postoperatively]
• Rate of device-related AE and SAEs [Срок оценки: During the procedure]
• Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye) [Срок оценки: During the procedure]
• Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye) [Срок оценки: During the procedure]

Критерии участия

Критерии включения

• Planned for sentinel lymph node biopsy at (or after) breast surgery
• Signed and dated written informed consent before the start of specific protocol procedures

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Швеция · 1 центр

• Sahlgrenska Iniversity Hospital — Gothenburg

Публикации

• 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. PMID 29855858
• 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. PMID 27782005
• 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. PMID 28877348
• 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 2 PMID 35000820
• 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 ear PMID 27117158
• 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. PMID 33572114

Идентификаторы

NCT: NCT06169072 · SUGBG-2022002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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