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Magnetic Seed vs Guidewire Breast Cancer Localization With Magnetic Lymph Node Detection
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery. Section for Breast Surgery, Department of Surgery, Uppsala University Hospital, Uppsala, Sweden.ORCID iD: 0000-0003-3654-335X
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Disciplinary Domain of Medicine and Pharmacy, research centers etc., Centre for Clinical Research, County of Västmanland. Section for Breast Surgery, Department of Surgery, Västmanlands County Hospital, Västerås, Sweden.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Disciplinary Domain of Medicine and Pharmacy, research centers etc., Centre for Clinical Research, County of Västmanland. Section for Breast Surgery, Department of Surgery, Västmanlands County Hospital, Västerås, Sweden.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology. Evidia Mammography Department, Uppsala, Sweden.
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2023 (English)In: JAMA Surgery, ISSN 2168-6254, E-ISSN 2168-6262Article in journal (Refereed) Epub ahead of print
Abstract [en]

Importance  Guidewires have been the standard for breast lesion localization but pose operative and logistic challenges. Paramagnetic seeds have shown promising results, but to the authors’ knowledge, no randomized comparison has been performed.

Objective  To determine whether the combination of a paramagnetic seed and superparamagnetic iron oxide (SPIO) is equivalent to guidewire and SPIO for breast cancer localization and sentinel lymph node detection (SLND).

Design, Setting, and Participants  This was a phase 3, pragmatic, equivalence, 2-arm, open-label, randomized clinical trial conducted at 3 university and/or community hospitals in Sweden from May 2018 to May 2022. Included in the study were patients with early breast cancer planned for breast conservation and SLND. Study data were analyzed July to November 2022.

Interventions  Participants were randomly assigned 1:1 to a paramagnetic seed or a guidewire. All patients underwent SLND with SPIO.

Main Outcomes and Measures  Re-excision rate and resection ratio (defined as actual resection volume / optimal resection volume).

Results  A total of 426 women (median [IQR] age, 65 [56-71] years; median [IQR] tumor size, 11 [8-15] mm) were included in the study. The re-excision rate was 2.90% (95% CI, 1.60%-4.80%), and the median (IQR) resection ratio was 1.96 (1.15-3.44). No differences were found between the guidewire and the seed in re-excisions (6 of 211 [2.84%] vs 6 of 209 [2.87%]; difference, −0.03%; 95% CI, −3.20% to 3.20%; P = .99) or resection ratio (median, 1.93; IQR, 1.18-3.43 vs median, 2.01; IQR, 1.11-3.47; P = .70). Overall SLN detection was 98.6% (95% CI, 97.1%-99.4%) with no differences between arms (203 of 207 [98.1%] vs 204 of 206 [99.0%]; difference, −0.9%; 95% CI, −3.6% to 1.8%; P = .72). More failed localizations occurred with the guidewire (21 of 208 [10.1%] vs 4 of 215 [1.9%]; difference, 8.2%; 95% CI, 3.3%-13.2%; P < .001). Median (IQR) time to specimen excision was shorter for the seed (15 [10-22] minutes vs 18 [12-30] minutes; P = .01), as was the total operative time (69 [56-86] minutes vs 75.5 [59-101] minutes; P = .03). The experience of surgeons, radiologists, and surgical coordinators was better with the seed.

Conclusions and Relevance  The combination of SPIO and a paramagnetic seed performed comparably with SPIO and guidewire for breast cancer conserving surgery and resulted in more successful localizations, shorter operative times, and better experience.

Trial Registration  ISRCTN.org Identifier: ISRCTN11914537

Place, publisher, year, edition, pages
American Medical Association (AMA), 2023.
National Category
Surgery Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-524259DOI: 10.1001/jamasurg.2023.6520ISI: 001134191000002PubMedID: 38150215OAI: oai:DiVA.org:uu-524259DiVA, id: diva2:1841789
Funder
Uppsala UniversityThe Breast Cancer FoundationAvailable from: 2024-02-29 Created: 2024-02-29 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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Pantiora, EiriniJazrawi, AllanHersi, Abdi-FatahAbdsaleh, ShahinWärnberg, FredrikEriksson, StaffanKarakatsanis, Andreas

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