Rajiv V Dave1, Emma Barrett2, Jenna Morgan3, Mihir Chandarana4, Suzanne Elgammal5, Nicola Barnes1, Amtul Sami4, Tahir Masudi6, Sue Down7, Chris Holcombe8, Shelley Potter9,10, Santosh K Somasundaram11, Matthew Gardiner12,13, Senthurun Mylvaganam14, Anthony Maxwell1,15, James Harvey1,16. 1. The Nightingale Breast Cancer Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK. 2. Department of Medical Statistics, Manchester University Hospitals NHS Foundation Trust, Wythenshawe Hospital, Manchester, UK. 3. Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK. 4. Breast Unit, Lincoln County Hospital, United Lincolnshire Hospitals NHS Trust, Lincoln, UK. 5. Breast Unit, University Hospital Crosshouse, NHS Ayrshire and Arran, Kilmarnock, UK. 6. Breast screening and assessment unit, Rotherham General Hospital, Rotherham NHS Foundation Trust, Rotherham, UK. 7. Breast Unit, James Paget University Hospital, Great Yarmouth, UK. 8. Breast Unit, Liverpool University Hospitals Foundation Trust, Liverpool, UK. 9. National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK. 10. Bristol Breast Care Centre, North Bristol NHS Trust, Bristol, UK. 11. Breast Screening Unit, Royal Lancaster Infirmary, Lancaster, UK. 12. Department of Plastic Surgery, Frimley Health NHS Foundation Trust, Slough, UK. 13. Kennedy Institute of Rheumatology, University of Oxford, Oxford, UK. 14. Health Education West Midlands, Royal Wolverhampton NHS Trust, Wolverhampton, UK. 15. Division of Informatics, Imaging & Data Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK. 16. Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Abstract
BACKGROUND: Wire localization is historically the most common method for guiding excision of non-palpable breast lesions, but there are limitations to the technique. Newer technologies such as magnetic seeds may allow some of these challenges to be overcome. The aim was to compare safety and effectiveness of wire and magnetic seed localization techniques. METHODS: Women undergoing standard wire or magnetic seed localization for non-palpable lesions between August 2018 and August 2020 were recruited prospectively to this IDEAL stage 2a/2b platform cohort study. The primary outcome was effectiveness defined as accurate localization and removal of the index lesion. Secondary endpoints included safety, specimen weight and reoperation rate for positive margins. RESULTS: Data were accrued from 2300 patients in 35 units; 2116 having unifocal, unilateral breast lesion localization. Identification of the index lesion in magnetic-seed-guided (946 patients) and wire-guided excisions (1170 patients) was 99.8 versus 99.1 per cent (P = 0.048). There was no difference in overall complication rate. For a subset of patients having a single lumpectomy only for lesions less than 50 mm (1746 patients), there was no difference in median closest margin (2 mm versus 2 mm, P = 0.342), re-excision rate (12 versus 13 per cent, P = 0.574) and specimen weight in relation to lesion size (0.15 g/mm2versus 0.138 g/mm2, P = 0.453). CONCLUSION: Magnetic seed localization demonstrated similar safety and effectiveness to those of wire localization. This study has established a robust platform for the comparative evaluation of new localization devices.
BACKGROUND: Wire localization is historically the most common method for guiding excision of non-palpable breast lesions, but there are limitations to the technique. Newer technologies such as magnetic seeds may allow some of these challenges to be overcome. The aim was to compare safety and effectiveness of wire and magnetic seed localization techniques. METHODS: Women undergoing standard wire or magnetic seed localization for non-palpable lesions between August 2018 and August 2020 were recruited prospectively to this IDEAL stage 2a/2b platform cohort study. The primary outcome was effectiveness defined as accurate localization and removal of the index lesion. Secondary endpoints included safety, specimen weight and reoperation rate for positive margins. RESULTS: Data were accrued from 2300 patients in 35 units; 2116 having unifocal, unilateral breast lesion localization. Identification of the index lesion in magnetic-seed-guided (946 patients) and wire-guided excisions (1170 patients) was 99.8 versus 99.1 per cent (P = 0.048). There was no difference in overall complication rate. For a subset of patients having a single lumpectomy only for lesions less than 50 mm (1746 patients), there was no difference in median closest margin (2 mm versus 2 mm, P = 0.342), re-excision rate (12 versus 13 per cent, P = 0.574) and specimen weight in relation to lesion size (0.15 g/mm2versus 0.138 g/mm2, P = 0.453). CONCLUSION: Magnetic seed localization demonstrated similar safety and effectiveness to those of wire localization. This study has established a robust platform for the comparative evaluation of new localization devices.
Authors: Patrik Pöschke; Julius Emons; Felix Heindl; Rüdiger Schulz-Wendtland; Sebastian Jud; Ramona Erber; Carolin C Hack; Caroline Preuss; Annika Behrens Journal: In Vivo Date: 2022 Sep-Oct Impact factor: 2.406