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Magnetic Technique for Sentinel Lymph Node Biopsy in Melanoma: The MELAMAG Trial

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

Abstract

Background

Sentinel lymph node biopsy (SLNB) in melanoma is currently performed using the standard dual technique (radioisotope and blue dye). The magnetic technique is non-radioactive and provides a brown color change in the sentinel lymph node (SLN) through an intradermal injection of a magnetic tracer, and utilizes a handheld magnetometer. The MELAMAG Trial compared the magnetic technique with the standard technique for SLNB in melanoma.

Methods

Clinically node-negative patients with primary cutaneous melanoma were recruited from four centers. SLNB was undertaken after intradermal administration of both the standard (blue dye and radioisotope) and magnetic tracers. The SLN identification rate per patient, with the two techniques, was compared.

Results

A total of 133 patients were recruited, 129 of which were available for final analysis. The sentinel node identification rate was 97.7 % (126/129) with the standard technique and 95.3 % (123/129) with the magnetic technique [2.3 % difference; 95 % upper confidence limit (CL) 6.4; 5.4 % discordance]. With radioisotope alone, the SLN identification rate was 95.3 % (123/129), as with the magnetic technique (0 % difference; 95 % upper CL 4.5; 7.8 % discordance). The lymph node retrieval rate was 1.99 nodes per patient overall, 1.78 with the standard technique and 1.87 with the magnetic technique.

Conclusions

The magnetic technique is feasible for SLNB in melanoma with a high SLN identification rate, but is associated with skin staining. When compared with the standard dual technique, it did not reach our predefined non-inferiority margin.

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Acknowledgments

The authors thank the patients and their relatives for participating in this trial, and also thank the research nurses and the National Institute for Health Research (NIHR) for helping recruiting patients into the trial, members of the Data Management Committee for their advice, and Endomagnetics Ltd (UK) for providing devices and maintaining them during the recruitment phase of this trial. The sponsors of this trial were King’s College London (UK), and Guy’s and St. Thomas’ NHS Foundation Trust (UK).

Author Contributions

Bauke Anninga, Samantha White, Marc Moncrieff, Peter Dziewulski, Jenny Geh, Joost Klaase, Hans Garmo, Fernanda Castro, Sarah Pinder, Quentin Pankhurst, Margaret Hall-Craggs, and Michael Douek participated in the design and concept of the study; Bauke Anninga, Samantha White, Marc Moncrieff, Peter Dziewulski, Jenny Geh, Joost Klaase, Fernanda Castro, and Michael Douek participated in the data collection and enrolment of participants in this study; Bauke Anninga, Hans Garmo, Fernanda Castro, and Michael Douek participated in the data analysis; and Bauke Anninga and Michael Douek drafted the manuscript. All authors interpreted the data and approved the final manuscript.

Conflicts of interest

Although one of the authors (Quentin Pankhurst) fulfills a part-time paid advisory role as Chief Scientist (Physics) for the magnetic SLNB company Endomagnetics Ltd, his role in this work has been purely academic. All other authors have no disclosures to make regarding financial and personal relationships with other people or organizations that could inappropriately influence their work.

Disclosures

None.

Funding

This work was supported by a grant from the Technology Strategy Board (now known as Innovate UK). The funder (Technology Strategy Board), as well as the manufacturer of the investigated devices (Endomagnetics Ltd, UK), had no role in the trial design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the trial and had final responsibility for the decision to submit the manuscript for publication.

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Authors and Affiliations

  1. Division of Cancer Studies, King’s College London, London, UK

    Bauke Anninga MSc, Hans Garmo PhD, Fernanda Castro PhD, Sarah Pinder MD & Michael Douek MD

  2. Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK

    Samantha H. White MBChB & Marc Moncrieff MD

  3. St Andrew’s Anglia Ruskin (StAAR) Research Unit, Anglia Ruskin University, Chelmsford, UK

    Peter Dziewulski FRCS

  4. Department of Plastic and Reconstructive Surgery, Guy’s and St. Thomas’ NHS Foundation Trust, London, UK

    Jenny L. C. Geh FRCSEdPLAST

  5. Department of Surgery, Medical Spectrum Twente, Enschede, The Netherlands

    Joost Klaase MD

  6. UCL Healthcare Biomagnetics Laboratory, University College London, London, UK

    Quentin A. Pankhurst PhD

  7. Centre for Medical Imaging, University College London, London, UK

    Margaret A. Hall-Craggs MD

Authors
  1. Bauke Anninga MSc
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  2. Samantha H. White MBChB
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  3. Marc Moncrieff MD
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  4. Peter Dziewulski FRCS
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  5. Jenny L. C. Geh FRCSEdPLAST
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  6. Joost Klaase MD
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  7. Hans Garmo PhD
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  8. Fernanda Castro PhD
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  9. Sarah Pinder MD
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  10. Quentin A. Pankhurst PhD
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  11. Margaret A. Hall-Craggs MD
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  12. Michael Douek MD
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Consortia

MELAMAG Multicentre Trialists Group

Corresponding author

Correspondence to Michael Douek MD.

Additional information

The members of MELAMAG Multicentre Trialists Group are given in Appendix.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 6647 kb)

Appendices

Appendix: MELAMAG Trialists Group (Trial Collaborators)

Prof. Michael Douek, CI, Chair of TMG (King’s College London, London, UK)

Prof. Peter Dziewulski, PI, Co-Chair of TMG (Broomfield Hospital, Chelmsford, UK)

Mr Muneer Ahmed (King’s College London, London, UK)

Mr Bauke Anninga, TMG (King’s College London, London, UK)

Dr Eduardo Calonje, Lead Pathologist (Guy’s and St. Thomas’ Hospitals, London, UK)

Dr Fernanda Castro, CTC, TMG (Guy’s and St. Thomas’ Hospitals, London, UK)

Dr Hans Garmo, STAT (King’s College London, London, UK)

Ms Jenny Geh, PI (Guy’s and St. Thomas’ Hospitals, London, UK)

Ms Samantha H. White, TMG (Norfolk and Norwich University Hospital, Norwich, UK)

Dr Bennie ten Haken, TMG (University of Twente, Enschede, The Netherlands)

Prof. Margaret A. Hall-Craggs, Lead Radiologist (University College Hospital, London, UK)

Dr Mark Harries (Guy’s and St. Thomas’ Hospitals, London, UK)

Mr Joost Klaase, PI, TMG (Medisch Spectrum Twente, Enschede, The Netherlands)

Dr Katie Lacy (Guy’s and St. Thomas’ Hospitals, London, UK)

Mr Dan Marsh (Broomfield Hospital, Chelmsford, UK)

Ms April Matthews, PA (Independent Cancer Patients’ Voice, London, UK)

Mr Marc Moncrieff, PI, TMG (Norfolk and Norwich University Hospital, Norwich, UK)

Mr Tom Oxenham (University College Hospital, London, UK)

Prof. Quentin A Pankhurst, TMG (University College London, London, UK)

Prof. Sarah Pinder (King’s College London, London, UK)

Mr Joost Pouw (University of Twente, Enschede, The Netherlands)

Ms Vernie Ramalingam, CTM, TMG (Guy’s and St. Thomas’ Hospitals, London, UK)

Prof. Tobias Scheaffter (King’s College London, London, UK)

Dr Rafael Torres De Rosales (King’s College London, London, UK)

Ms Susan Vreemann (University of Twente, Enschede, The Netherlands)

Key: CI Chief Investigator, TMG Trial Management Group, PI Principal Investigator, CTC Clinical Trial Coordinator, STAT Statistician, PA Patient Advocate, CTM Clinical Trial Manager

Surgical Collaborators

Mr Naguib El-Muttardi (Broomfield Hospital, Chelmsford, UK)

Mr Quentin Frew (Broomfield Hospital, Chelmsford, UK)

Mr Martin Heaton (Norfolk and Norwich University Hospital, Norwich, UK)

Mr Kenneth Kok (Norfolk and Norwich University Hospital, Norwich, UK)

Mr Alastair MacKenzie-Ross (Guy’s and St. Thomas’ Hospitals, London, UK)

Mr Daniel Marsh (Broomfield Hospital, Chelmsford, UK)

Ms Sankhya Sen (Broomfield Hospital, Chelmsford, UK)

Mr Nicholas Sheppard (Norfolk and Norwich University Hospital, Norwich, UK)

Mr Mobinulla Syed (Broomfield Hospital, Chelmsford, UK)

Mr Ewan Wilson (Norfolk and Norwich University Hospital, Norwich, UK)

Research Nurses and Trial Coordinators

Ms Karen Collins (Broomfield Hospital, Chelmsford, UK)

Ms Fiona Mc Neela (Broomfield Hospital, Chelmsford, UK)

Ms Vernie Ramalingam (Guy’s and St. Thomas’ Hospitals, London, UK)

Ms Sweta Sethi (Guy’s and St. Thomas’ Hospitals, London, UK)

Ms Anja Stam (Medisch Spectrum Twente, Enschede, The Netherlands)

Ms Beverly Underwood (Norfolk and Norwich University Hospital, Norwich, UK)

Ms Sara Wilkinson (Norfolk and Norwich University Hospital, Norwich, UK)

Data Monitoring Committee (Independent)

Dr Jurgen Fütterer, Interventional Radiologist (University Medical Centre Nijmegen, Nijmegen, The Netherlands)

Mr Antonio Orlando, Consultant Plastic Surgeon (North Bristol NHS Trust, Bristol, UK)

Ms Jane Warwick, Statistician (University of London, London, UK)

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Anninga, B., White, S.H., Moncrieff, M. et al. Magnetic Technique for Sentinel Lymph Node Biopsy in Melanoma: The MELAMAG Trial. Ann Surg Oncol 23, 2070–2078 (2016). https://doi.org/10.1245/s10434-016-5113-7

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