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Randomized controlled trial comparing magnetic marker localization (MaMaLoc) with wire-guided localization in the treatment of early-stage breast cancer |
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| Authors: | Gerson M Struik MSc MD PhD Bram Schermers MSc Ingeborg Mares MSc MD PhD Harold E Lont MSc MD Jennifer W Bradshaw MSc MD Bernard ten Haken MSc Ir PhD Theo J M Ruers MSc MD PhD Jurgen E M Mourik PhD Erwin Birnie MSc PhD Taco M A L Klem MSc MD PhD |
| Affiliation: | 1. Department of Surgery, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands;2. Department of Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Technical Medical Centre, University of Twente, Enschede, The Netherlands;3. Department of Radiology, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands;4. Technical Medical Centre, University of Twente, Enschede, The Netherlands;5. Department of Medical Physics, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands;6. Department of Statistics and Education, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands Department of Genetics, University Medical Centre Groningen, University of Groningen, Amsterdam, The Netherlands |
| Abstract: | Wire-guided localization (WGL) is the standard of care in the surgical treatment of nonpalpable breast tumors. In this study, we compare the use of a new magnetic marker localization (MaMaLoc) technique to WGL in the treatment of early-stage breast cancer patients. Open-label, single-center, randomized controlled trial comparing MaMaLoc (intervention) to WGL (control) in women with early-stage breast cancer. Primary outcome was surgical usability measured using the System Usability Scale (SUS, 0–100 score). Secondary outcomes were patient reported, clinical, and pathological outcomes such as retrieval rate, operative time, resected specimen weight, margin status, and reoperation rate. Thirty-two patients were analyzed in the MaMaLoc group and 35 in the WGL group. Patient and tumor characteristics were comparable between groups. No in situ complications occurred. Retrieval rate was 100% in both groups. Surgical usability was higher for MaMaLoc: 70.2 ± 8.9 vs. 58.1 ± 9.1, p < 0.001. Patients reported higher overall satisfaction with MaMaLoc (median score 5/5) versus WGL (score 4/5), p < 0.001. The use of magnetic marker localization (MaMaLoc) for early-stage breast cancer is effective and has higher surgical usability than standard WGL. |
| Keywords: | breast carcinoma magnetism nonradioactive patient satisfaction surgery surgical usability trial registration tumor localization |
