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Optimizing the magnetic tracer technique for sentinel lymph node detection and tumour localization in breast cancer surgery
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Disciplinary Domain of Medicine and Pharmacy, research centers etc., Centre for Clinical Research, County of Västmanland.
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 [en]
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: urn:nbn:se:uu:diva-525195ISBN: 978-91-513-2073-1 (print)OAI: oai:DiVA.org:uu-525195DiVA, id: diva2:1845391
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
List of papers
1. Magnetic Seed vs Guidewire Breast Cancer Localization With Magnetic Lymph Node Detection
Open this publication in new window or tab >>Magnetic Seed vs Guidewire Breast Cancer Localization With Magnetic Lymph Node Detection
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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:nbn:se:uu:diva-524259 (URN)10.1001/jamasurg.2023.6520 (DOI)001134191000002 ()38150215 (PubMedID)
Funder
Uppsala UniversityThe Breast Cancer Foundation
Available from: 2024-02-29 Created: 2024-02-29 Last updated: 2024-04-03Bibliographically approved
2. A Comparison of Skin Staining after Sentinel Lymph Node Biopsy in Women Undergoing Breast Cancer Surgery Using Blue Dye and Superparamagnetic Iron Oxide Nanoparticle (SPIO) Tracers
Open this publication in new window or tab >>A Comparison of Skin Staining after Sentinel Lymph Node Biopsy in Women Undergoing Breast Cancer Surgery Using Blue Dye and Superparamagnetic Iron Oxide Nanoparticle (SPIO) Tracers
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2022 (English)In: Cancers, ISSN 2072-6694, Vol. 14, no 23, article id 6017Article in journal (Refereed) Published
Abstract [en]

Simple Summary Both superparamagnetic iron oxide nanoparticles (SPIO) and blue dye (BD) have been reported to cause skin staining after breast-conserving surgery. SPIO is a novel tracer that has been shown to identify sentinel lymph nodes (SLNs) in patients with breast cancer. Our study was the first to compare the incidence and size of skin staining between the two tracers. We reported on these outcomes in a preplanned secondary analysis of a prospective clinical trial in which women received both SPIO and BD. This study investigated whether there was a difference in the incidence and size of skin staining between SPIO and BD after SLN-dissection. In all, 270 women were operated on with breast-conserving surgery and received SPIO, and 204 of these women also received BD. After 24 months of follow up, there was no statistically significant difference between the two tracers with regard to the size and incidence of skin staining. Superparamagnetic iron oxide nanoparticles (SPIO) are a tracer for sentinel lymph node (SLN) detection. In a preplanned secondary analysis of a prospective clinical trial (SentiDose) we reported on skin staining after SPIO and blue dye (BD) injections. For SPIO, either a 1.5 mL retroareolar injection on the day of surgery or a 1.0 mL peritumoral/retroareolar injection 1-7 days before surgery was given. A 1.0 mL sub-/intradermal periareolar injection of BD was also administered to all these women. Staining was then assessed at 6, 12 and 24 months after surgery. A total of 270 women received SPIO and were operated on with breast-conserving surgery. Of these, 204 women also received BD. A total of 58 (21.5%) women had an SPIO stain 6 months postoperatively with a median size of 6.8 cm(2) (p = 0.56), while 51 (25.0%) had a BD stain with a median size of 8.5 cm(2) (p = 0.93). The incidence and size of SPIO and BD staining decreased over time reciprocally. At 24 months, the incidence and median size of SPIO was 23 (8.6%) and 4 cm(2), respectively. For BD, the incidence was 14 (6.3%, p = 0.13), and the median size was 3.5 cm(2) (p = 0.18). There was, therefore, no statistically significant difference in the incidence or size of skin staining between SPIO and BD over time.

Place, publisher, year, edition, pages
MDPI, 2022
Keywords
sentinel lymph node biopsy, breast cancer, blue dye, superparamagnetic iron oxide, magnetic tracer, sentinel lymph node, skin staining
National Category
Surgery
Identifiers
urn:nbn:se:uu:diva-492358 (URN)10.3390/cancers14236017 (DOI)000897533100001 ()36497498 (PubMedID)
Funder
The Breast Cancer Foundation
Available from: 2023-01-04 Created: 2023-01-04 Last updated: 2024-04-03Bibliographically approved
3. Prospective evaluation of MRI artefacts following breast conserving surgery and sentinel lymph node dissection with the magnetic technique.
Open this publication in new window or tab >>Prospective evaluation of MRI artefacts following breast conserving surgery and sentinel lymph node dissection with the magnetic technique.
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(English)Manuscript (preprint) (Other academic)
National Category
Surgery
Research subject
Surgery
Identifiers
urn:nbn:se:uu:diva-524261 (URN)
Available from: 2024-02-29 Created: 2024-02-29 Last updated: 2024-04-03
4. 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
Open this publication in new window or tab >>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
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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
MDPIMDPI, 2021
Keywords
sentinel lymph node biopsy, breast cancer, superparamagnetic iron oxide, magnetic tracer, sentinel lymph node
National Category
Surgery
Identifiers
urn:nbn:se:uu:diva-456477 (URN)10.3390/cancers13174285 (DOI)000694127400001 ()34503095 (PubMedID)
Available from: 2021-10-21 Created: 2021-10-21 Last updated: 2024-04-03Bibliographically approved

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