| 1. |
- Hersi, Abdi-Fatah, et al.
(författare)
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A combined, totally magnetic technique with a magnetic marker for non-palpable tumour localization and superparamagnetic iron oxide nanoparticles for sentinel lymph node detection in breast cancer surgery
- 2019
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Ingår i: European Journal of Surgical Oncology. - : Elsevier BV. - 0748-7983 .- 1532-2157. ; 45:4, s. 544-549
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Tidskriftsartikel (refereegranskat)abstract
- Background: Surgery for non-palpable breast cancer may often be a challenging procedure. Recently, a magnetic seed (Magseed®) used for tumour localization has been developed. Superparamagnetic iron oxide nanoparticles (SPIO) for sentinel lymph node (SN) detection is a novel tracer that may be injected up to four weeks preoperatively. This study is the first combining the magnetic seed and SPIO.Material and methods: Patients planned for breast conserving surgery and SN-biopsy (SNB) were recruited from two units in Sweden. Patients underwent lesion localization with Magseed® and SPIO injection (Magtrace™) by the breast radiologist in the preoperative period. Feasibility of successful lesion localization and excision together with a successful SNB detection was evaluated. Seed migration, number of SNs, specimen volume and calculated resection ratio (CRR) were reported.A survey of the physicians’ experience was conducted.Results: Localization was performed at a median of three days before surgery (range 0–25). All 32 patients underwent microscopically radical resection with a CRR of 1.49. No seed migration was noticed. SNB was successful in all patients. A median of two SNs was retrieved. Radiologists and surgeons reported the procedure easy to learn and outperformed guidewire localization in terms of localization and excision time. They thought the technique facilitated planning localization and surgery.Conclusions: The combined magnetic technique provided accuracy in tumour localization and SN detection without excess tissue excision and with promising results for flexibility in delivery of care. Larger studies are needed to confirm these findings.
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| 2. |
- Hersi, Abdi-Fatah, 1989-, et al.
(författare)
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A Randomised Clinical Trial comparing Magseed® with Guide Wire localization in nonpalpable breast cancer scheduled for Magtrace® assisted sentinel lymph node biopsy: The MagTotal RCT
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Guidewire localization is widely regarded as the gold standard method of localizing non-palpable breast tumors even though it has drawbacks. Magnetic seed (magseed®) localization is a safe and feasible alternative for localizing and excising non-palpable breast tumors. The combination of magnetic seed localization together with superparamagnetic iron oxide nanoparticles (SPIO) for breast cancer scheduled for breast-conserving surgery (BCS) together with sentinel lymph node biopsy (SLNB) have also been reported. In this multicentre randomized pilot study, we aimed to compare localization with either Magseed® or guidewire in breast cancer patients scheduled for BCS + SLNB between September 2018 and May 2021. All patients received SPIO peritumoral and preoperatively for identification of the sentinel lymph nodes (SLN). If randomized to magseed® localization (n = 91) the patient received it by the radiologist up until 30 days before surgery and if allocated to guidewire localization (n = 116) the patient received it on the day of the surgery. All patients were injected with SPIO, ultrasound guided by radiologist if allocated to magnetic seed or by the surgeon if allocated to guidewire, up until 30 days before surgery. Primary endpoint was reoperation rate due to positive margins. In 207 patients (n = 91 in magseed and n = 116 in guidewire) there was no significant difference in reoperation rate (3.3% in magseed vs 7% in guidewire group, p = 0.354). Furthermore, there was no significant difference in SLN detection rate (97.8% vs 100%, p = 0.187) and both groups had comparable mean number of SLNs retrieved (2.52 vs 2.62 nodes, p = 0.763). Magnetic seed localization together with SPIO for SLNB is a viable and safe alternative to guidewire localization.
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| 3. |
- Hersi, Abdi-Fatah, et al.
(författare)
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Optimizing Dose and Timing in Magnetic Tracer Techniques for Sentinel Lymph Node Detection in Early Breast Cancers: The Prospective Multicenter SentiDose Trial
- 2021
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Ingår i: Cancers. - : MDPI AG. - 2072-6694. ; 13:4
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Tidskriftsartikel (refereegranskat)abstract
- Simple Summary Superparamagnetic iron oxide (SPIO) nanoparticles have comparable performance to the combination of radioisotope and blue dye (RI + BD) for sentinel lymph node (SLN) biopsy in breast cancer. In this multicenter prospective study, lower SPIO doses (undiluted 1.5 vs. 1.0 mL) in different timeframes (perioperative vs. 1-7 days preoperative) and injection sites (subareolar vs. peritumoral) were compared to the previous standard (diluted 2.0 mL perioperatively) from the earlier Nordic trial. RI + BD were co-administered as background. In total, 534 patients were analyzed. SPIO SLN detection rates were similar (97.5% vs. 100% vs. 97.6%, p = 0.11) and respectively non-inferior to the dual technique. Significantly more SLNs were retrieved in the preoperative 1.0 mL cohort compared with 1.5 mL and the Nordic cohorts (2.18 vs. 1.85 vs. 1.83, p = 0.003). Thus, SPIO at 1.5 and 1.0 mL was non-inferior to both Sienna+(R) and the dual technique for SLN detection. Superparamagnetic iron oxide nanoparticles (SPIO) are non-inferior to radioisotope and blue dye (RI + BD) for sentinel lymph node (SLN) detection. Previously, 2 mL SPIO (Sienna+(R)) in 3 mL NaCl was used. In this dose-optimizing study, lower doses of a new refined SPIO solution (Magtrace(R)) (1.5 vs. 1.0 mL) were tested in different timeframes (0-24 h perioperative vs. 1-7 days preoperative) and injections sites (subareolar vs. peritumoral). Two consecutive breast cancer cohorts (n = 328) scheduled for SLN-biopsy were included from 2017 to 2019. All patients received isotope +/- blue dye as back-up. SLNs were identified primarily with the SentiMag(R) probe and thereafter a gamma-probe. The primary endpoint was SLN detection rate with SPIO. Analyses were performed as a one-step individual patient-level meta-analysis using patient-level data from the previously published Nordic Trial (n = 206) as a third, reference cohort. In 534 patients, the SPIO SLN detection rates were similar (97.5% vs. 100% vs. 97.6%, p = 0.11) and non-inferior to the dual technique. Significantly more SLNs were retrieved in the preoperative 1.0 mL cohort compared with 1.5 and the 2.0 mL cohorts (2.18 vs. 1.85 vs. 1.83, p = 0.003). Lower SPIO volumes injected up to 7 days before the operation have comparable efficacy to standard SPIO dose and RI + BD for SLN detection.
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| 4. |
- Hersi, Abdi-Fatah, 1989-
(författare)
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Superparamagnetic iron oxide nanoparticles, a novel tracer in breast cancer surgery
- 2021
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The most common surgical choice of treatment in breast cancer is breast-conserving surgery (BCS) together with sentinel lymph node biopsy (SNB). Around 10% of breast cancer diagnosis are ductal carcinoma in situ (DCIS). Superparamagnetic iron oxide nanoparticles (SPIO) are a novel tracer for sentinel lymph node (SN) detection. The aim of this thesis was to investigate the unique applications and functionality of a magnetic approach in breast cancer surgery.Paper I was a two-centre pilot study of 32 patients with non-palpable breast cancer who were scheduled for BCS together with SNB. They received SPIO for SNB and a magnetic seed (Magseed®) for localization of the breast tumour. All 32 patients underwent microscopically radical resection and SNB was successfully performed in all included patients.Paper II was a multicentre prospective single-cohort study. It was a pre-planned interim analysis of 189 patients with “high-risk” DCIS who received SPIO at primary surgery but without performing SNB. If an invasive breast cancer was shown by the final histopathology report, the patient was scheduled for second surgery to undergo SNB. Because SPIO has a much longer half-life than the radioisotope, the magnetic signal at the second surgery was sufficient for detecting SNs; in fact, in patients with DCIS, it reduced from around 50% to 22%. Paper III was a multicentre prospective trial. Two consecutive cohorts of patients with breast cancer scheduled for SNB (n = 328) were included. Lower doses of a refined SPIO suspension were tested in different time frames and injection sites. Analyses were performed as a one-step individual patient-level meta-analysis using patient-level data from a similar previous cohort (n = 206) as a third reference group. In 534 patients, the SPIO SN detection rates were comparable (97.5% vs. 100% vs. 97.6%, p = 0.11) and were noninferior to the dual technique. Paper IV was a multicentre randomized pilot trial aimed to compare tumour localization in nonpalpable breast cancers using either Magseed® or guidewire in patients scheduled for BCS + SNB. All patients received SPIO for the SNB preoperatively. Patients who were randomized to the magnetic seed cohort received their Magseed® at the same time as the SPIO injection preoperatively while the guidewire placement was performed on the same day as surgery. In 207 patients, there were no significant differences in reoperation rate (3% in the magnetic seed cohort vs 7% in the guidewire cohort, p = 0.35).
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| 5. |
- Jazrawi, Allan, et al.
(författare)
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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
- 2022
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Ingår i: Cancers. - : MDPI AG. - 2072-6694. ; 14:23
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 6. |
- Karakatsanis, Andreas, et al.
(författare)
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Effect of preoperative injection of superparamagnetic iron oxide particles on rates of sentinel lymph node dissection in women undergoing surgery for ductal carcinoma in situ (SentiNot study)
- 2019
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Ingår i: British Journal of Surgery. - : Oxford University Press (OUP). - 0007-1323 .- 1365-2168. ; 106:6, s. 720-
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Tidskriftsartikel (refereegranskat)abstract
- Background: One-fifth of patients with a preoperative diagnosis of ductal carcinoma in situ (DCIS) have invasive breast cancer (IBC) on definitive histology. Sentinel lymph node dissection (SLND) is performed in almost half of women having surgery for DCIS in Sweden. The aim of the present study was to try to minimize unnecessary SLND by injecting superparamagnetic iron oxide (SPIO) nanoparticles at the time of primary breast surgery, enabling SLND to be performed later, if IBC is found in the primary specimen. Methods: Women with DCIS at high risk for the presence of invasion undergoing breast conservation, and patients with DCIS undergoing mastectomy were included. The primary outcome was whether this technique could reduce SLND. Secondary outcomes were number of SLNDs avoided, detection rate and procedure-related costs. Results: This was a preplanned interim analysis of 189 procedures. IBC was found in 47 and a secondary SLND was performed in 41 women. Thus, 78.3 per cent of patients avoided SLND (P<0.001). At reoperation, SPIO plus blue dye outperformed isotope and blue dye in detection of the sentinel node (40 of 40 versus 26 of 40 women; P<0.001). Costs were reduced by a mean of 24.5 per cent in women without IBC (3990 versus 5286; P<0.001). Conclusion: Marking the sentinel node with SPIO in women having surgery for DCIS was effective at avoiding unnecessary SLND in this study. Registration number: ISRCTN18430240 (http://www.isrctn.com).
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| 7. |
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| 8. |
- Pantiora, Eirini, et al.
(författare)
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Magnetic Seed vs Guidewire Breast Cancer Localization With Magnetic Lymph Node DetectionA Randomized Clinical Trial
- 2024
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Ingår i: JAMA SURGERY. - : American Medical Association (AMA). - 2168-6254 .- 2168-6262.
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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