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Simplifying Logistics and Avoiding the Unnecessary in Patients with Breast Cancer Undergoing Sentinel Node Biopsy. A Prospective Feasibility Trial of the Preoperative Injection of Super Paramagnetic Iron Oxide Nanoparticles
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för kirurgiska vetenskaper, Endokrinkirurgi.
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för immunologi, genetik och patologi, Klinisk och experimentell patologi.
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för kirurgiska vetenskaper, Endokrinkirurgi.
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centrum för klinisk forskning, Västerås.
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2018 (engelsk)Inngår i: Scandinavian Journal of Surgery, ISSN 1457-4969, E-ISSN 1799-7267, Vol. 107, nr 2, s. 130-137Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

PURPOSE: Sentinel node is routinely localized with the intraoperative use of a radioactive tracer, involving challenging logistics. Super paramagnetic iron oxide nanoparticle is a non-radioactive tracer with comparable performance that could allow for preoperative localization, would simplify the procedure, and possibly be of value in axillary mapping before neoadjuvant treatment. The current trial aimed to determine the a priori hypothesis that the injection of super paramagnetic iron oxide nanoparticles in the preoperative period for the localization of the sentinel node is feasible.

METHODS: This is a prospective feasibility trial, conducted from 9 September 2014 to 22 October 2014 at Uppsala University Hospital. In all, 12 consecutive patients with primary breast cancer planned for resection of the primary and sentinel node biopsy were recruited. Super paramagnetic iron oxide nanoparticles were injected in the preoperative visit in the outpatient clinic. The radioactive tracer (99mTc) and the blue dye were injected perioperatively in standard fashion. A volunteer was injected with super paramagnetic iron oxide nanoparticles to follow the decline in the magnetic signal in the sentinel node over time. The primary outcome was successful sentinel node detection.

RESULTS: Super paramagnetic iron oxide nanoparticles' detection after preoperative injection (3-15 days) was successful in all cases (100%). In the volunteer, axillary signal was presented for 4 weeks. No adverse effects were noted. Conclusion and relevance: Preoperative super paramagnetic iron oxide nanoparticles' injection is feasible and leads to successful detection of the sentinel node. That may lead to simplified logistics as well as the identification, sampling, and marking of the sentinel node in patients planned for neoadjuvant treatment.

sted, utgiver, år, opplag, sider
2018. Vol. 107, nr 2, s. 130-137
Emneord [en]
Super paramagnetic iron oxide, breast cancer, novel technique, sentinel node biopsy
HSV kategori
Forskningsprogram
Kirurgi; Patologi
Identifikatorer
URN: urn:nbn:se:uu:diva-335970DOI: 10.1177/1457496917738867ISI: 000432717600006PubMedID: 29132268OAI: oai:DiVA.org:uu-335970DiVA, id: diva2:1164532
Tilgjengelig fra: 2017-12-11 Laget: 2017-12-11 Sist oppdatert: 2019-04-02bibliografisk kontrollert
Inngår i avhandling
1. Sentinel Node Biopsy for Breast Cancer: Aspects and evolution
Åpne denne publikasjonen i ny fane eller vindu >>Sentinel Node Biopsy for Breast Cancer: Aspects and evolution
2018 (engelsk)Doktoravhandling, med artikler (Annet vitenskapelig)
Abstract [en]

Sentinel Node Biopsy (SNB) in clinical practice was pivotal to the shaping of modern diagnosis, staging and treatment of patients with breast cancer. The use of radioisotope (RI) and blue dye (BD) has led to high detection rates with low false negatives, but delivery-of-care limitations connected to these tracers as well as the need for methods addressing new clinical conundrums delineates the urge for new tracers with comparable performance, easier logistics and, ideally expanded implementations. Aim of the present thesis is to examine the outcomes of Superparamagnetic Iron Oxide (SPIO) nanoparticles, a new tracer based on magnetism for the detection of the sentinel nodes.

Paper I is a prospective multicentre trial comparing SPIO to RI+BD, with all tracers injected at the same patient. In 206 patients, SPIO had a similar detection rate (97.6 vs 97.1%, p=0.76) whereas concordance between methods was 98%. The study was completed by a meta-analysis of similar trials published until that point. The detection rates were comparable (fixed OR:1.10; 0.67,1.79, p=0.71), and so was concordance between tracers (fixed RD: 0.00; -0.01, 0.01, p=0.82). Discoloration was present after periareolar SPIO injection in 39% of patients, almost exclusively treated with breast conservation, which reduced to 8.6% after 15 months of follow-up.

Paper II was a pilot study of twelve patients with breast cancer and SNB performed where SPIO and the combination of RI+BD were injected, but SPIO was injected up to 15 days preoperatively, with total success in detection and complete concordance.

Paper III tested the performance of SPIO as a sole tracer in a pragmatic double-arm non-randomised trial comparing it to the combination of RI+BD. Detection was 95.7% for SPIO and 96.8% for RI (p = 0.59). The preoperative injection of SPIO (1-27 d) enhanced SPIO specific detection (95.7 vs 86%, p=0.002).

Paper IV is an interim analysis of a multicentre cohort study including patients with high-risk DCIS planned for breast conservation or any DCIS planned for mastectomy. SPIO was injected to “mark” the sentinel node but SNB was performed in a second operation only if invasive cancer was found at the first operation. In 151 included patients, this technique led to avoidance of 81.5% SNB, with a cost reduction of 14.1% for the entire cohort and 25.8% for the patients that did not have invasive cancer. The detection rate at reoperation was superior for SPIO and comparable with SNB detection at primary operation.

In conclusion, SPIO is a novel tracer for SNB in breast cancer with comparable performance, fit for performance in a global setting and with wider clinical implementations compared to RI+BD.

sted, utgiver, år, opplag, sider
Uppsala: Acta Universitatis Upsaliensis, 2018. s. 78
Serie
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1491
Emneord
Breast Cancer, Sentinel Node Biopsy, Superparamagnetic Iron Oxide
HSV kategori
Identifikatorer
urn:nbn:se:uu:diva-358236 (URN)978-91-513-0423-6 (ISBN)
Disputas
2018-10-12, Rosénsalen, Akademiska sjukhuset, ing 95-96, Uppsala, 09:00 (engelsk)
Opponent
Veileder
Tilgjengelig fra: 2018-09-21 Laget: 2018-08-26 Sist oppdatert: 2018-10-02

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