Evidence map›Paper›PMID 27117158›Full record

Trial reportBreast cancer research and treatment2016

The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc(99) and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies.

Andreas Karakatsanis, Peer Michael Christiansen, Lone Fischer, Christina Hedin, Lida Pistioli, Malin Sund, Nils Ryegaard Rasmussen, Hjørdis Jørnsgård, Daniel Tegnelius, Staffan Eriksson and 4 more

3 registry-linked trialsOpen access · hybridAbstract readClinical TrialComparative StudyMulticenter Study
In one paragraph

Trial report in Breast cancer research and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 61 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 5 pooled it
5.2field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05288686 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Use of Superparamagnetic Iron Oxide (SPIO) Versus Conventional Radioisotope and Patent Blue Dye in Sentinel Lymph Node Detection for Breast Cancer: a Randomized Controlled Trial

TypeinterventionalSponsorThe University of Hong KongRan2018 to 2024Enrolled282ConditionsBreast Cancer, Sentinel Lymph NodeArmssentinel lymph node biopsy procedure
NCT05359783 phase1 / phase2completednot on this mapstarted 2021, after this paper: background citation

Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging and Magnetic Probe in Patients with Breast Cancer

TypeinterventionalSponsorVastra Gotaland RegionRan2021 to 2024Enrolled50ConditionsBreast Cancer, Sentinel Lymph NodeArmsSuperparamagnetic Iron Oxide
NCT06169072 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer

TypeinterventionalSponsorVastra Gotaland RegionRan2023 to 2027Enrolled220ConditionsBreast Cancer, Sentinel Lymph NodeArmsSuperparamagnetic Iron Oxide, Technetium99
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 5 syntheses or guidelines pooled it, 143 citations in OpenAlex.

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1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 2 countries.

Andreas KarakatsanisSection for Endocrine and Breast Surgery, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden. andreas.karakatsanis@akademiska.se.
Peer Michael ChristiansenBreast Unit, Department of Surgery, Aarhus University Hospital/Randers Regional Hospital, Aarhus, Denmark.
Lone FischerBreast Unit, Department of Surgery, Aarhus University Hospital/Randers Regional Hospital, Aarhus, Denmark.
Christina HedinBreast Unit, Department of Surgery, Linköping University Hospital, Linköping, Sweden.
Lida PistioliBreast Unit, Department of Surgery, Linköping University Hospital, Linköping, Sweden.
Malin SundDepartment of Surgical and Perioperative Sciences, Umeå, Sweden.
Nils Ryegaard RasmussenBreast Unit, Department of Surgery, SVS, Esbjerg, Denmark.
Hjørdis JørnsgårdBreast Unit, Department of Surgery, SVS, Esbjerg, Denmark.
Daniel TegneliusBreast Unit, Department of Surgery, Örebro University Hospital, Örebro, Sweden.
Staffan ErikssonDepartment of Surgery, Västmanland County Hospital, Västerås, Sweden.
Kosmas DaskalakisSection for Endocrine and Breast Surgery, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Fredrik WärnbergSection for Endocrine and Breast Surgery, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Christos J MarkopoulosMedical School, National and Kapodistrian University, Athens, Greece.
Leif BergkvistCenter for Clinical Research Uppsala University and Department of Surgery, Västmanland County Hospital, Västerås, Sweden.
Uppsala University Hospital · SEAarhus University Hospital · DKHospital South West Jutland · DKLinköping University Hospital · SEÖrebro University Hospital · SEUmeå University · SEUppsala University · SEVästmanlands sjukhus Västerås · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of the study is to compare the efficacy of SPIO as a tracer in sentinel node biopsy (SNB) in breast cancer with Tc and patent blue in a multicentre prospective study and perform a meta-analysis of all published studies. It also aims to follow skin discoloration after SPIO injection and describe when and how it resolves. Totally 206 patients with early breast cancer were recruited. Tc and patent blue were administered in standard fashion. Patients were injected with SPIO (Sienna+) preoperatively. SNB was performed and detection rates were recorded for both methods. Skin discoloration was followed and documented postoperatively. Data extraction and subsequent meta-analysis of all previous studies were also performed. SN detection rates were similar between standard technique succeeded and SPIO both per patient (97.1 vs. 97.6 %, p = 0.76) as well as per node (91.3 vs. 93.3 %, p = 0.34), something which was not affected by the presence of malignancy. Concordance rates were also consistently high (98.0 % per patient and 95.9 % per node). Discoloring was present in 35.5 % of patients postoperatively, almost exclusively in breast conservation. It fades slowly and is still detectable in 8.6 % of patients after 15 months. Meta-analysis depicted similar detection rates (p = 0.71) and concordance rates (p = 0.82) per patient. However, it seems that SPIO is characterized by higher nodal retrieval (p < 0.001). SPIO is an effective method for the detection of SN in patients with breast cancer. It is comparable to the standard technique and seems to simplify logistics. Potential skin discoloration is something of consideration in patients planned for breast conservation.

Indexed as

Breast NeoplasmsColoring AgentsDenmarkFemaleFerric CompoundsHumansMagnetite NanoparticlesMiddle AgedProspective StudiesRadiopharmaceuticalsRosaniline DyesSentinel Lymph NodeSentinel Lymph Node BiopsySwedenTechnetium Tc 99m Aggregated AlbuminColoring AgentsFerric Compoundsferric oxideMagnetite NanoparticlesRadiopharmaceuticalsRosaniline Dyessulfan blueTechnetium Tc 99m Aggregated AlbuminBreast cancerSentinel nodeSuper paramagnetic iron oxide

Identifiers

PMID27117158
PMCPMC4875068
OpenAlexW2343305861

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.