Skip to main content
Top
Published in: Annals of Surgical Oncology 6/2016

01-06-2016 | Melanomas

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

Authors: Bauke Anninga, MSc, Samantha H. White, MBChB, Marc Moncrieff, MD, Peter Dziewulski, FRCS, Jenny L. C. Geh, FRCSEdPLAST, Joost Klaase, MD, Hans Garmo, PhD, Fernanda Castro, PhD, Sarah Pinder, MD, Quentin A. Pankhurst, PhD, Margaret A. Hall-Craggs, MD, Michael Douek, MD, MELAMAG Multicentre Trialists Group

Published in: Annals of Surgical Oncology | Issue 6/2016

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
go back to reference Wong SL, Balch CM, Hurley P, et al. Sentinel lymph node biopsy for melanoma: American Society of Clinical Oncology and Society of Surgical Oncology joint clinical practice guideline. J Clin Oncol. 2012;30(23):2912–18.CrossRefPubMed Wong SL, Balch CM, Hurley P, et al. Sentinel lymph node biopsy for melanoma: American Society of Clinical Oncology and Society of Surgical Oncology joint clinical practice guideline. J Clin Oncol. 2012;30(23):2912–18.CrossRefPubMed
2.
go back to reference Morton DL, Thompson JF, Cochran AJ, et al. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med. 2014;370(7):599–609.CrossRefPubMedPubMedCentral Morton DL, Thompson JF, Cochran AJ, et al. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med. 2014;370(7):599–609.CrossRefPubMedPubMedCentral
3.
go back to reference Valsecchi ME, Silbermins D, de Rosa N, Wong SL, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in patients with melanoma: a meta-analysis. J Clin Oncol. 2011;29(11):1479–87.CrossRefPubMed Valsecchi ME, Silbermins D, de Rosa N, Wong SL, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in patients with melanoma: a meta-analysis. J Clin Oncol. 2011;29(11):1479–87.CrossRefPubMed
4.
go back to reference Morton DL, Thompson JF, Essner R, et al. Validation of the accuracy of intraoperative lymphatic mapping and sentinel lymphadenectomy for early-stage melanoma: a multicenter trial. Multicenter Selective Lymphadenectomy Trial Group. Ann Surg. 1999;230(4):453–63 (Discussion 463–455). Morton DL, Thompson JF, Essner R, et al. Validation of the accuracy of intraoperative lymphatic mapping and sentinel lymphadenectomy for early-stage melanoma: a multicenter trial. Multicenter Selective Lymphadenectomy Trial Group. Ann Surg. 1999;230(4):453–63 (Discussion 463–455).
5.
go back to reference Neves RI, Reynolds BQ, Hazard SW, Saunders B, Mackay DR. Increased post-operative complications with methylene blue versus lymphazurin in sentinel lymph node biopsies for skin cancers. J Surg Oncol. 2011;103(5):421–25.CrossRefPubMed Neves RI, Reynolds BQ, Hazard SW, Saunders B, Mackay DR. Increased post-operative complications with methylene blue versus lymphazurin in sentinel lymph node biopsies for skin cancers. J Surg Oncol. 2011;103(5):421–25.CrossRefPubMed
6.
go back to reference Morton DL, Cochran AJ, Thompson JF, et al. Sentinel node biopsy for early-stage melanoma: accuracy and morbidity in MSLT-I, an international multicenter trial. Ann Surg. 2005;242(3):302–11 (Discussion 311–303). Morton DL, Cochran AJ, Thompson JF, et al. Sentinel node biopsy for early-stage melanoma: accuracy and morbidity in MSLT-I, an international multicenter trial. Ann Surg. 2005;242(3):302–11 (Discussion 311–303).
7.
go back to reference Barthelmes L, Goyal A, Newcombe RG, et al. Adverse reactions to patent blue V dye: the NEW START and ALMANAC experience. Eur J Surg Oncol. 2010;36(4):399–403.CrossRefPubMed Barthelmes L, Goyal A, Newcombe RG, et al. Adverse reactions to patent blue V dye: the NEW START and ALMANAC experience. Eur J Surg Oncol. 2010;36(4):399–403.CrossRefPubMed
8.
go back to reference Leong SP, Donegan E, Heffernon W, Dean S, Katz JA. Adverse reactions to isosulfan blue during selective sentinel lymph node dissection in melanoma. Ann Surg Oncol. 2000;7(5):361–66.CrossRefPubMed Leong SP, Donegan E, Heffernon W, Dean S, Katz JA. Adverse reactions to isosulfan blue during selective sentinel lymph node dissection in melanoma. Ann Surg Oncol. 2000;7(5):361–66.CrossRefPubMed
9.
go back to reference Stratmann SL, McCarty TM, Kuhn JA. Radiation safety with breast sentinel node biopsy. Am J Surg. 1999;178(6):454–57.CrossRefPubMed Stratmann SL, McCarty TM, Kuhn JA. Radiation safety with breast sentinel node biopsy. Am J Surg. 1999;178(6):454–57.CrossRefPubMed
10.
go back to reference Ruth TJ. The medical isotope crisis: how we got here and where we are going. J Nucl Med Technol. 2014;42(4):245–48.CrossRefPubMed Ruth TJ. The medical isotope crisis: how we got here and where we are going. J Nucl Med Technol. 2014;42(4):245–48.CrossRefPubMed
11.
go back to reference Ahmed M, Purushotham AD, Douek M. Novel techniques for sentinel lymph node biopsy in breast cancer: a systematic review. Lancet Oncol. 2014;15(8):e351–62.CrossRefPubMed Ahmed M, Purushotham AD, Douek M. Novel techniques for sentinel lymph node biopsy in breast cancer: a systematic review. Lancet Oncol. 2014;15(8):e351–62.CrossRefPubMed
12.
go back to reference Joshi T, Pankhurst QA, S. H, Douek M. Magnetic nanoparticles for detecting cancer spread. Breast Cancer Res Treat. 2007;1006(1):S129. Joshi T, Pankhurst QA, S. H, Douek M. Magnetic nanoparticles for detecting cancer spread. Breast Cancer Res Treat. 2007;1006(1):S129.
13.
go back to reference Johnson L, Douek M. Magnetic sentinel lymph node detection for breast cancer. Cancer Res. 2010;70:140s. Johnson L, Douek M. Magnetic sentinel lymph node detection for breast cancer. Cancer Res. 2010;70:140s.
14.
go back to reference 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. 2014;21(4):1237–45.CrossRefPubMed 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. 2014;21(4):1237–45.CrossRefPubMed
15.
go back to reference Piñero-Madrona A, Torró-Richart JA, de León-Carrillo JM, et al. Superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: a comparative non-inferiority study. Eur J Surg Oncol. 2015;41(8):991–97.CrossRefPubMed Piñero-Madrona A, Torró-Richart JA, de León-Carrillo JM, et al. Superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: a comparative non-inferiority study. Eur J Surg Oncol. 2015;41(8):991–97.CrossRefPubMed
16.
go back to reference Rubio IT, Diaz-Botero S, Esgueva A, et al. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015;41(1):46–51.CrossRefPubMed Rubio IT, Diaz-Botero S, Esgueva A, et al. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015;41(1):46–51.CrossRefPubMed
17.
go back to reference Thill M, Kurylcio A, Welter R, et al. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014;23(2):175–79.CrossRefPubMed Thill M, Kurylcio A, Welter R, et al. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014;23(2):175–79.CrossRefPubMed
18.
go back to reference Winter A, Woenkhaus J, Wawroschek F. A novel method for intraoperative sentinel lymph node detection in prostate cancer patients using superparamagnetic iron oxide nanoparticles and a handheld magnetometer: the initial clinical experience. Ann Surg Oncol. 2014;21(13):4390–96.CrossRefPubMedPubMedCentral Winter A, Woenkhaus J, Wawroschek F. A novel method for intraoperative sentinel lymph node detection in prostate cancer patients using superparamagnetic iron oxide nanoparticles and a handheld magnetometer: the initial clinical experience. Ann Surg Oncol. 2014;21(13):4390–96.CrossRefPubMedPubMedCentral
19.
go back to reference Anninga B, Ahmed M, Douek M. Magnetic guidance for cancer surgery. Br J Surg. 2015;102(2):e12–14.CrossRefPubMed Anninga B, Ahmed M, Douek M. Magnetic guidance for cancer surgery. Br J Surg. 2015;102(2):e12–14.CrossRefPubMed
20.
go back to reference Newcombe RG. Improved confidence intervals for the difference between binomial proportions based on paired data. Stat Med. 1998;17(22):2635–50.CrossRefPubMed Newcombe RG. Improved confidence intervals for the difference between binomial proportions based on paired data. Stat Med. 1998;17(22):2635–50.CrossRefPubMed
21.
go back to reference Ahmed M, de Rosales RT, Douek M. Preclinical studies of the role of iron oxide magnetic nanoparticles for nonpalpable lesion localization in breast cancer. J Surg Res. 2013;185(1):27–35.CrossRefPubMed Ahmed M, de Rosales RT, Douek M. Preclinical studies of the role of iron oxide magnetic nanoparticles for nonpalpable lesion localization in breast cancer. J Surg Res. 2013;185(1):27–35.CrossRefPubMed
Metadata
Title
Magnetic Technique for Sentinel Lymph Node Biopsy in Melanoma: The MELAMAG Trial
Authors
Bauke Anninga, MSc
Samantha H. White, MBChB
Marc Moncrieff, MD
Peter Dziewulski, FRCS
Jenny L. C. Geh, FRCSEdPLAST
Joost Klaase, MD
Hans Garmo, PhD
Fernanda Castro, PhD
Sarah Pinder, MD
Quentin A. Pankhurst, PhD
Margaret A. Hall-Craggs, MD
Michael Douek, MD
MELAMAG Multicentre Trialists Group
Publication date
01-06-2016
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 6/2016
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-016-5113-7

Other articles of this Issue 6/2016

Annals of Surgical Oncology 6/2016 Go to the issue