Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer

Karakatsanis, Andreas; Daskalakis, Kosmas; Stålberg, Peter; Olofsson, Helena; Andersson, Yvette; Eriksson, Staffan; Bergkvist, Leif; Wärnberg, Fredrik

doi:10.1002/bjs.10606

Cited by 58 publications

(70 citation statements)

References 30 publications

(58 reference statements)

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“…In those studies, patients received injections of both SPIO and 99m Tc, with or without blue dye. To address the concern of whether the results can be influenced by the presence of both tracers, a subsequent clinical trial evaluated the use of SPIO alone and compared it with 99m Tc; the results showed that the detection rates were comparable for both methods …”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, magnetic methods are easier and safer, and those can replace the RI method in the future, even in facilities with radiation‐controlled areas. The price for both methods is comparable, and there is no dependence on radioactive isotope supply nor a need for radiation‐controlled areas and imaging facilities with the magnetic method. More accurate SLNB will lead to a reduction in the number of patients waiting for surgery (the wait time in Japan is around 1‐3 months), further reducing health care costs.…”

Section: Discussionmentioning

confidence: 99%

“…To address the concern of whether the results can be influenced by the presence of both tracers, a subsequent clinical trial evaluated the use of SPIO alone and compared it with 99m Tc; the results showed that the detection rates were comparable for both methods. 20 Here, we present a SLNB clinical trial using Resovist, the only magnetic substance particle that can be currently used in Japan, and a miniature probe that we newly developed. This study demonstrated that this method was not inferior to the conventional RI method.…”

Section: Discussionmentioning

confidence: 99%

“…21 Furthermore, magnetic methods are easier and safer, and those can replace the RI method in the future, even in facilities with radiation-controlled areas. The price for both methods is comparable, 20 and there is no dependence on radioactive isotope supply nor a need for radiation-controlled areas and imaging facilities with the Abbreviations: n, number of cases; 95% CI, 95% confidence interval. magnetic method.…”

Section: Discussionmentioning

confidence: 99%

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Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe

Taruno

Kurita

Kuwahata

et al. 2019

Journal of Surgical Oncology

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Background Sentinel lymph node biopsy is a standard staging procedure for early axillary lymph node‐negative breast cancer. As an alternative to the currently used radioactive tracers for sentinel lymph node (SLN) detection during the surgical procedure, a number of studies have shown promising results using superparamagnetic iron oxide (SPIO) nanoparticles. Here, we developed a new handheld, cordless, and lightweight magnetic probe for SPIO detection. Methods Resovist (SPIO nanoparticles) were detected by the newly developed handheld probe, and the SLN detection rate was compared to that of the standard radioisotope (RI) method using radioactive colloids (99mTc) and a blue dye (indigo carmine). This was a multicenter prospective clinical trial that included 220 patients with breast cancer scheduled for sentinel node biopsy after a clinical diagnosis of negative axillary lymph node from three facilities in Japan. Results Of the 210 patients analyzed, SLN was detected in 94.8% (199/210 cases, 90% confidence interval [CI]) with our magnetic method and in 98.1% (206/210 cases, 90% CI) with the RI method. The magnetic method exceeded the threshold identification rate of 90%. Conclusion This was the first clinical study to use a novel handheld magnetometer to detect SLN, which we demonstrate to be not inferior to the RI method.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe

Taruno

Kurita

Kuwahata

et al. 2019

Journal of Surgical Oncology

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“…Injection of SPIO avoids use of nuclear medicine resources and does not involve a steep learning curve. It has the additional advantage that the signal persists for up to 1 month after injection, allowing SLND at a later date, potentially after the first operation.…”

Section: Introductionmentioning

confidence: 99%

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)

Karakatsanis

Hersi

Pistioli

et al. 2019

British Journal of Surgery

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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

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Magnetic Seed vs Guidewire Breast Cancer Localization With Magnetic Lymph Node Detection

Pantiora,

Jazrawi,

Hersi

et al. 2024

JAMA Surg

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ImportanceGuidewires 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsParticipants were randomly assigned 1:1 to a paramagnetic seed or a guidewire. All patients underwent SLND with SPIO.Main Outcomes and MeasuresRe-excision rate and resection ratio (defined as actual resection volume / optimal resection volume).ResultsA 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 &lt; .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 RelevanceThe 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 RegistrationISRCTN.org Identifier: ISRCTN11914537

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Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer

Cited by 58 publications

References 30 publications

Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe

Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe

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)

Magnetic Seed vs Guidewire Breast Cancer Localization With Magnetic Lymph Node Detection

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