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Sentinel Node Biopsy Using a Magnetic Tracer Versus Standard Technique: The SentiMAG Multicentre Trial

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

The SentiMAG Multicentre Trial evaluated a new magnetic technique for sentinel lymph node biopsy (SLNB) against the standard (radioisotope and blue dye or radioisotope alone). The magnetic technique does not use radiation and provides both a color change (brown dye) and a handheld probe for node localization. The primary end point of this trial was defined as the proportion of sentinel nodes detected with each technique (identification rate).

Methods

A total of 160 women with breast cancer scheduled for SLNB, who were clinically and radiologically node negative, were recruited from seven centers in the United Kingdom and The Netherlands. SLNB was undertaken after administration of both the magnetic and standard tracers (radioisotope with or without blue dye).

Results

A total of 170 SLNB procedures were undertaken on 161 patients, and 1 patient was excluded, leaving 160 patients for further analysis. The identification rate was 95.0 % (152 of 160) with the standard technique and 94.4 % (151 of 160) with the magnetic technique (0.6 % difference; 95 % upper confidence limit 4.4 %; 6.9 % discordance). Of the 22 % (35 of 160) of patients with lymph node involvement, 16 % (25 of 160) had at least 1 macrometastasis, and 6 % (10 of 160) had at least a micrometastasis. Another 2.5 % (4 of 160) had isolated tumor cells. Of 404 lymph nodes removed, 297 (74 %) were true sentinel nodes. The lymph node retrieval rate was 2.5 nodes per patient overall, 1.9 nodes per patient with the standard technique, and 2.0 nodes per patient with the magnetic technique.

Conclusions

The magnetic technique is a feasible technique for SLNB, with an identification rate that is not inferior to the standard technique.

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Acknowledgment

The authors thank the patients and their relatives for participating in this trial. They also thank the research nurses and the National Institute of Health Research (NIHR) for helping recruit patients into the trial; the Clinical Research Coordinator (Medische Spectrum Twente, Enschede, The Netherlands) for helping with patient recruitment and data management; members of the Data Monitoring Committee for their valuable advice (Miss Zoe Winters, Dr. Jane Warwick, and Dr. Jurgen Fütterer); Endomagnetics Ltd. (UK) for providing an educational grant to fund this clinical trial. This work was supported by the Experimental Cancer Medicine Centre Initiative which is jointly funded by Cancer Research UK, the NIHR in England and the Departments of Health for Scotland, Wales and Northern Ireland. The research was also supported by the NIHR Biomedical Research Centre based at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London. The sponsors of this trial are King’s College London, UK and Guy’s & St Thomas’ Hospitals NHS Foundation Trust.

Funding

Unrestricted Education Grant from Endomagnetics Ltd., UK. UK National Institute of Health Research (NIHR) adopted trial.

Disclosure

None.

Author information

Authors and Affiliations

Authors

Consortia

Corresponding author

Correspondence to Michael Douek MD.

Additional information

This study was conducted on behalf of the SentiMAG Trialists Group (Study Collaborators).

The members of the SentiMAG Trialists Group (Study Collaborators) are listed in the Appendix.

Ethics Committee application numbers—UK: 6/2/12 ref: 11/LO/1972; The Netherlands: NL39018.044.11.

Protocol version: 6.0, October 8, 2012.

Trial Registrations: ISRCTN: 35827879 (http://www.controlled-trials.com/ISRCTN35827879/); The Netherlands: NTR3283 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3283).

UK National Cancer Research Network (NCRN) Adoption: April 17, 2012.

Appendix

Appendix

SentiMAG Trialists Group (Study Collaborators)

Mr Michael Douek, CI, Chair of TMG (King’s College London). Prof Arnie Purushotham, Co-Chair TMG (King’s College London); arniepurushotham@gmail.com. Mr Muneer Ahmed, TMG (King’s College London); muneer.ahmed@kcl.ac.uk. Mr Bauke Anninga, CTC, TMG (King’s College London); bauke.anninga@kcl.ac.uk. Mr Douglas Brown, PI, TMG (Ninewell’s Hospital and Medical School, Dundee, UK); douglasbrown@nhs.net. Dr Fernanda Castro, CTM, TMG (Guy’s & St Thomas’ Hospitals, London); fernanda.castro@gstt.nhs.uk. Professor Philip Drew, PI, TMG (Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, UK); philip.drew@rcht.cornwall.nhs.uk. Mr Joost Klaase, PI, TMG (Medisch Spectrum Twente, Enschede, The Netherlands); j.klaase@mst.nl. Dr Hans Garmo STAT, TMG (King’s College London); hans.garmo@kcl.ac.uk. Mr Maarten Grootendorst, CTC, TMG (King’s College London); maarten.grootendorst@kcl.ac.uk. Dr Bennie ten Haken, TMG (MIRA-NeuroImaging, University of Twente, Enschede, The Netherlands); b.tenhaken@utwente.nl. Mr Ashutosh Kothari, TMG (Guy’s & St Thomas’ Hospitals); ashutosh.kothari@gstt.nhs.uk. Professor Margaret Hall-Craggs, TMG (University College Hospital, London); margaret.hall-craggs@uclh.nhs.uk. Janet MacSweeney, TMG (King’s College London); janet.mac_sweeney@kcl.ac.uk.  Mrs April Matthews BSc(Hon), PA, TMG (ICPV - Independent Cancer Patients’ Voice, London); april.a.matthews@gmail.com. Mr Ian James Monypenny, PI, TMG (University Hospital of Wales at Llandough, Cardiff, UK); ian.monypenny@wales.nhs.uk. Dr Agbaje Olorunsola, STAT, TMG (King’s College London); olorunsola.agbaje@kcl.ac.uk. Professor Quentin Pankhurst, TMG (University College London); q.pankhurst@ucl.ac.uk. Ms Vernie Ramalingam, CTM, TMG (Guy’s & St Thomas’ Hospitals, London); vernie.ramalingam@gstt.nhs.uk. Mr Simon Pilgrim, TMG (Norwich and Norfolk University Hospitals, Norwich, UK); sipilgrim@hotmail.com. Professor Sarah Pinder, TMG (King’s College London); sarah.pinder@kcl.ac.uk. Joost Pouw, MSc, TMG (MIRA-NeuroImaging, University of Twente, Enschede, The Netherlands); j.j.pouw@utwente.nl. Ms Lynda Wyld, PI, TMG (University of Sheffield, Sheffield, UK); l.wyld@sheffield.ac.uk. Miss Katalin Zechmeister, PI, TMG (Norwich and Norfolk University Hospitals, Norwich, UK); katalin.zechmeister@nnuh.nhs.uk.

Key: CI - Chief Investigator; PI - Principal Investigator; TMG - Trial Management Group; STAT - Statistician; CTM - Clinical Trial Manager; CTC - Clinical Trial Co-ordinator; PA - Patient Advocate (Independent Cancer Patient Voice); DMC - Data Monitoring Committee.

Surgical Collaborators

Guy’s & St Thomas’ Hospitals, London, UK: Mr W Al Sarakbi; wail.alsarakbi@gstt.nhs.uk. Mr H Hamed; hisham.hamed@gstt.nhs.uk. Mr M Kontos; michalis.kontos@gstt.nhs.uk. Mr T Kontoulis; theodoros.kontoulis@gstt.nhs.uk. Mr T Kovacs; tibor.kovacs@gstt.nhs.uk. Mr Y Masannat; yazanmas@hotmail.com. Miss A Suyoi; amalinda.suyoi@gstt.nhs.uk.

Medisch Spectrum Twente, Enschede, The Netherlands: Dr J Gerritsen; j.gerritsen@mst.nl. Dr W Mastboom; w.mastboom@mst.nl. Dr P Steenvoorde; p.steenvoorde@mst.nl. Dr E B van Duyn; e.vanduyn@mst.nl.

University Hospital of Wales at Llandough, Cardiff, UK: Ms E Davies; eleri.davies8@wales.nhs.uk. Mr S Goyal; sumit.goyal@wales.nhs.uk. Prof. H Sweetland;  sweetland@cf.ac.uk. Prof. R E Mansel; manselre@cf.ac.uk.

Norwich and Norfolk University Hospitals, Norwich, UK: Mr M Hussein; maged.hussein@nnuh.nhs.uk. Mr Gabor Peley; gabor.peley@nnuh.nhs.uk. Mr S Pain; simon.pain@nnuh.nhs.uk.

University of Sheffield, Sheffield, UK: Miss V Chandran; vidya.Chandran@sth.nhs.uk Prof M Reed; m.w.reed@sheffield.ac.uk.

Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, UK: Mr I  Abbas; imran.abbas@rcht.cornwall.nhs.uk; Mr I Brown; iain.brown@rcht.cornwall.nhs.uk. Mr M El-Gammel; mohsen.elgammal@rcht.cornwall.nhs.uk. Miss R English; rachel.english@rcht.cornwall.nhs.uk. Miss P King; polly.King@rcht.cornwall.nhs.uk.

Research Nurses

Joann McGrath (Norwich and Norfolk University Hospitals, Norwich, UK); joann.mcgrath@nnuh.nhs.uk. Laura McCabe (University of Sheffield, Sheffield, UK); l.mccabe@sheffield.ac.uk. Sadie Mitchell  (Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, UK); sadie.mitchell@rcht.cornwall.nhs.uk. Chris Morris (University Hospital of Wales at Llandough, Cardiff, UK); christine.morris3@wales.nhs.uk. Rachael Reid (Ninewells Hospital and Medical School, Dundee, UK); rachaelreid@nhs.net. Anja Stam (Medisch Spectrum Twente, Enschede, The Netherlands); researchbureau.heelkunde@mst.nl.

Data Monitoring Committee (independent)

Dr Jane Warwick, Imperial College London, Senior Lecturer in Clinical Trials Statistics, UK DMC. Dr Jurgen Fütterer, University Medical Centre Nijmegen, Body and Interventional Radiologist, The Netherlands DMC. Miss Zoe Winters, Senior Lecturer in Surgery, Bristol University, Consultant Surgeon, UK DMC.

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Douek, M., Klaase, J., Monypenny, I. et al. Sentinel Node Biopsy Using a Magnetic Tracer Versus Standard Technique: The SentiMAG Multicentre Trial. Ann Surg Oncol 21, 1237–1245 (2014). https://doi.org/10.1245/s10434-013-3379-6

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