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Magnetic-Guided Axillary UltraSound (MagUS) Sentinel Lymph Node Biopsy and Mapping in Patients with Early Breast Cancer. A Phase 2, Single-Arm Prospective Clinical Trial
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Disciplinary Domain of Medicine and Pharmacy, research centers etc., Centre for Clinical Research, County of Västmanland. Uppsala Univ, Ctr Clin Res, S-72189 Västerås, County Vastmanl, Sweden.;Vastmanlands Cty Hosp, Dept Surg, S-72189 Västerås, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery. Uppsala Univ, Dept Surg Sci, S-75185 Uppsala, Sweden.;Uppsala Univ Hosp, Dept Surg, Sect Endocrine & Breast Surg, S-75185 Uppsala, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology. Uppsala Univ, Dept Surg Sci, S-75185 Uppsala, Sweden.;Aleris Mammog Unit, S-75320 Uppsala, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Clinical and experimental pathology.
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2021 (English)In: Cancers, ISSN 2072-6694, Vol. 13, no 17, article id 4285Article in journal (Refereed) Published
Abstract [en]

Simple Summary Superparamagnetic iron oxide nanoparticles (SPIO) have been shown to identify sentinel lymph nodes (SLNs) in patients with breast cancer. This study investigated whether a minimally invasive approach with MRI-LG after SPIO injection in the breast followed by a magnetic guided axillary ultrasound and core biopsy of the SLN (MagUS) could accurately stage the axilla. The study included not only patients planned for primary surgery but also patients with recurrent cancer after previous surgery, but also patients scheduled for neoadjuvant treatment (NAT). The latter underwent minimally invasive SLNB prior to treatment and had their SLN clipped; surgery in the axilla was performed after NAT. In 79 included patients, MagUS detected all patients with macrometastasis and performed comparably with surgical sentinel lymph node dissection (SLND). It also allowed for marking of the SLN in patients planned for PST and enabled tailored decision making in breast cancer recurrence. Lymph Node Dissection (SLND) is standard of care for diagnosing sentinel lymph node (SLN) status in patients with early breast cancer. Study aim was to determine whether the combination of Superparamagnetic iron oxide nanoparticles (SPIO) MRI-lymphography (MRI-LG) and a Magnetic-guided Axillary UltraSound (MagUS) with biopsy can allow for minimally invasive, axillary evaluation to de-escalate surgery. Patients were injected with 2 mL of SPIO and underwent MRI-LG for SN mapping. Thereafter MagUS and core needle biopsy (CNB) were performed. Patients planned for neoadjuvant treatment, the SLN was clipped and SLND was performed after neoadjuvant with the addition of isotope. During surgery, SLNs were controlled for signs of previous biopsy or clip. The primary endpoint was MagUS SLN detection rate, defined as successful SLN detection of at least one SLN of those retrieved in SLND. In 79 patients, 48 underwent upfront surgery, 12 received neoadjuvant and 19 had recurrent cancer. MagUS traced the SLN in all upfront and neoadjuvant cases, detecting all patients with macrometastases (n = 10). MagUS missed only one micrometastasis, outperforming baseline axillary ultrasound AUS (AUC: 0.950 vs. 0.508, p < 0.001) and showing no discordance to SLND (p = 1.000). MagUS provides the niche for minimally invasive axillary mapping that can reduce diagnostic surgery.

Place, publisher, year, edition, pages
MDPI MDPI, 2021. Vol. 13, no 17, article id 4285
Keywords [en]
sentinel lymph node biopsy, breast cancer, superparamagnetic iron oxide, magnetic tracer, sentinel lymph node
National Category
Surgery
Identifiers
URN: urn:nbn:se:uu:diva-456477DOI: 10.3390/cancers13174285ISI: 000694127400001PubMedID: 34503095OAI: oai:DiVA.org:uu-456477DiVA, id: diva2:1605004
Available from: 2021-10-21 Created: 2021-10-21 Last updated: 2024-04-03Bibliographically approved
In thesis
1. Optimizing the magnetic tracer technique for sentinel lymph node detection and tumour localization in breast cancer surgery
Open this publication in new window or tab >>Optimizing the magnetic tracer technique for sentinel lymph node detection and tumour localization in breast cancer surgery
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Breast cancer is the most common form of cancer in women, and the primary treatment modalities are still breast-conserving surgery (BCS) and sentinel lymph node dissection (SLND) in most cases. Superparamagnetic iron oxide nanoparticles (SPIO) are gaining momentum as a tracer for sentinel lymph node detection. The aim of this thesis is to further refine the magnetic method and investigate its postoperative effects.

Paper I: This feasibility study, involving 79 patients, explored the use of SPIO-guided Magnetic resonance imaging (MRI)-lymphography and magnetic-guided axillary ultrasound (MagUS) with core biopsy for sentinel lymph node (SLN) localization and SLN status. MagUS, outperformed baseline axillary ultrasound and successfully traced SLNs in all cases, detecting macro-metastases accurately and missed only one micro-metastasis. The findings suggest that the MagUS technique enables minimally invasive approach in axillary mapping that can meet tailored patient needs and reduce the need for diagnostic surgery. 

Paper II: This study aimed to compare skin staining incidence and size between different doses of SPIO and blue dye (BD), evaluating their persistence over time. Among 270 women receiving SPIO, 204 also received BD. At six months, 21.5% had SPIO stains and 25% had BD stains Incidence and size decreased reciprocally, with no significant difference between the tracers regarding skin staining after 24 months. 

Paper III: This study compared the magnetic technique using Magseed® for non-palpable breast tumor localization with guidewire localization and SPIO for sentinel lymph node detection. In a prospective analysis of 426 women, reoperation rates, resection ratios, and SLN detection were assessed. No significant differences were found between the techniques in terms of re-excisions, resection ratios, or SLN detection. However, the magnetic technique showed more successful localizations, shorter operation time, and better overall experience among surgeons, radiologists, and theater coordinators, making it a good alternative for BCS.

Paper IV: In this prospective observational study, the impact of postoperative MRI outcome was explored in patients undergoing BCS with a peritumoral SPIO injection for SLN detection. The study affirms SPIO as a safe tracer for SLN detection without compromising MRI interpretation after BCS, ensuring reliable breast cancer recurrence assessment.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2024. p. 58
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 2036
Keywords
Breast Cancer, Sentinel Node, Super paramagnetic ironoxide nanoparticles, SPIO, Skin Staining, Magnetic resonance imaging, magnetic seed, guidewire
National Category
Surgery
Research subject
Surgery
Identifiers
urn:nbn:se:uu:diva-525195 (URN)978-91-513-2073-1 (ISBN)
Public defence
2024-05-16, Ingång 21, Västmanlands Sjukhus Västerås, Västerås, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2024-04-23 Created: 2024-03-18 Last updated: 2024-05-08

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Abdsaleh, ShahinVasiliu-Bacovia, DanielEriksson, StaffanWärnberg, FredrikKarakatsanis, Andreas

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Jazrawi, AllanPantiora, EiriniAbdsaleh, ShahinVasiliu-Bacovia, DanielEriksson, StaffanWärnberg, FredrikKarakatsanis, Andreas
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