{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T10:35:00Z","timestamp":1787567700497,"version":"build-2736575974"},"reference-count":22,"publisher":"MDPI AG","issue":"17","license":[{"start":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T00:00:00Z","timestamp":1787356800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background: Neoadjuvant systemic therapy (NST) enables tumor downsizing and increases the feasibility of breast-conserving surgery (BCS) in patients with early breast cancer (EBC). Reliable tumor localization after NST remains challenging, particularly in patients with a complete clinical response. If clips are not visible on ultrasound, stereotactic mammography-guided wire localization is required, which involves additional radiation exposure and may increase patient discomfort and procedural complexity. The 3D-shaped Tumark\u00ae Vision clip may enable ultrasound-guided localization after NST. Methods: In this prospective multicenter registry study (NCT04468113), 324 patients with biopsy-proven EBC scheduled for NST and breast-conserving surgery were enrolled across 19 German centers. Clip placement was performed under ultrasound guidance prior to NST, and clip detectability was assessed at predefined time points during therapy (4\u20138, 9\u201312, and \u226513 weeks after treatment initiation). Detection rates, visualization, and preoperative localization methods were recorded. Non-detectable clips required stereotactic wire localization, whereas ultrasound-guided localization was performed for detectable clips. Results: The preoperative detection rate was 91.1%. Clip detectability was higher in patients with longer NST durations and partial response by imaging. Ultrasound-guided wire localization was feasible in 214 patients (83.9%); among these, 165 patients (64.7%) underwent localization without and 49 patients (19.2%) with post-procedural mammographic verification. Stereotactic localization was required in 41 patients (16.1%), primarily due to non-visualization of the clip on ultrasound. The accuracy of ultrasound for residual tumor assessment was moderate (72.0%), with a sensitivity of 70.7%, indicating limitations in its ability to reliably assess residual tumor extent as a standalone modality. Conclusions: The 3D nickel\u2013titanium clip enables ultrasound-guided tumor localization after NST in the majority of patients with early breast cancer, although additional mammographic guidance remains necessary in a relevant proportion of cases.<\/jats:p>","DOI":"10.3390\/diagnostics16172684","type":"journal-article","created":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T09:20:02Z","timestamp":1787563202000},"page":"2684","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Ultrasound-Visible 3D Nickel\u2013Titanium Clip for Tumor Localization After Neoadjuvant Therapy in Early Breast Cancer: A Prospective Multicenter Real-World Study"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1381-8595","authenticated-orcid":false,"given":"Mattea","family":"Reinisch","sequence":"first","affiliation":[{"name":"Interdisciplinary Breast Unit, Kliniken Essen-Mitte, 45136 Essen, Germany"},{"name":"Interdisciplinary Breast Unit, University Medical Center Mannheim, University of Heidelberg, 68167 Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-4853-3052","authenticated-orcid":false,"given":"Efstathia","family":"Cremer","sequence":"additional","affiliation":[{"name":"Interdisciplinary Breast Unit, Kliniken Essen-Mitte, 45136 Essen, Germany"},{"name":"Department of Gynecology with Breast Center Charit\u00e9-Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin, 10117 Berlin, Germany"},{"name":"Center for Familial Breast and Ovarian Cancer, Institute for Hereditary Cancers, Center for Integrated Oncology (CIO), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50937 Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kilian","family":"Pankert","sequence":"additional","affiliation":[{"name":"Breast Unit, Diakonissen-Stiftungs-Krankenhaus Speyer, 67346 Speyer, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Weber","sequence":"additional","affiliation":[{"name":"Breast Unit, St. Barbara Klinik Hamm-Heessen, 59073 Hamm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Volker","family":"Hanf","sequence":"additional","affiliation":[{"name":"Breast Unit, Klinikum F\u00fcrth, 90766 F\u00fcrth, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katja","family":"Engellandt","sequence":"additional","affiliation":[{"name":"Breast Unit, Ev. Bethesda Krankenhaus Duisburg, 47053 Duisburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Hentsch","sequence":"additional","affiliation":[{"name":"Breast Unit, St\u00e4dtisches Klinikum Solingen, 42653 Solingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cordula","family":"M\u00fcller","sequence":"additional","affiliation":[{"name":"Breast Unit, Kreiskrankenhaus Bergstra\u00dfe Heppenheim, 64646 Heppenheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Dall","sequence":"additional","affiliation":[{"name":"Breast Unit, St\u00e4dtisches Klinikum L\u00fcneburg gGmbH, 21339 L\u00fcneburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Losch","sequence":"additional","affiliation":[{"name":"Breast Unit, Prosper-Hospital gGmbH, Kreis Recklinghausen, 45659 Recklinghausen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Deuschle","sequence":"additional","affiliation":[{"name":"Breast Unit, Marienhaus Klinikum Hetzelstift Neustadt, 67434 Neustadt an der Weinstrasse, Germany"},{"name":"Diakonissenkrankenhaus Speyer, Medizinisches Versorgungszentrum Rhein-Haardt, Gyn\u00e4kologie, 67346 Speyer, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Traut","sequence":"additional","affiliation":[{"name":"Interdisciplinary Breast Unit, Kliniken Essen-Mitte, 45136 Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satyen","family":"Shenoy","sequence":"additional","affiliation":[{"name":"Interdisciplinary Breast Unit, Kliniken Essen-Mitte, 45136 Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Engel","sequence":"additional","affiliation":[{"name":"Interdisciplinary Breast Unit, Kliniken Essen-Mitte, 45136 Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorothea","family":"Schindowski","sequence":"additional","affiliation":[{"name":"Interdisciplinary Breast Unit, Kliniken Essen-Mitte, 45136 Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9355-494X","authenticated-orcid":false,"given":"Sherko","family":"Kuemmel","sequence":"additional","affiliation":[{"name":"Interdisciplinary Breast Unit, Kliniken Essen-Mitte, 45136 Essen, Germany"},{"name":"Department of Gynecology with Breast Center Charit\u00e9-Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin, 10117 Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Gipe","sequence":"additional","affiliation":[{"name":"Interdisciplinary Breast Unit, Kliniken Essen-Mitte, 45136 Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1634\/theoncologist.2018-0228","article-title":"Neoadjuvant Management of Early Breast Cancer: A Clinical and Investigational Position Statement","volume":"24","author":"Colomer","year":"2019","journal-title":"Oncologist"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1159\/000545019","article-title":"AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2025","volume":"20","author":"Albert","year":"2025","journal-title":"Breast Care"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1016\/j.clinimag.2018.07.003","article-title":"Breast tissue markers: Why? 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Oncol."}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/16\/17\/2684\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T09:34:23Z","timestamp":1787564063000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/16\/17\/2684"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,22]]},"references-count":22,"journal-issue":{"issue":"17","published-online":{"date-parts":[[2026,9]]}},"alternative-id":["diagnostics16172684"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics16172684","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,22]]}}}