Abstract P3-12-16: MELODY: A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions (EUBREAST-4 / iBRA-NET, NCT 05559411)

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Abstract Background: In the last decades, the proportion of breast cancer patients receiving breast-conserving surgery has increased, reaching 70-80% in developed countries. In case of non-palpable lesions, surgical excision requires some form of breast localization. While wire-guided localization has long been considered gold standard, it carries several limitations, including logistical difficulties, the potential for displacement and patient discomfort, and re-excision rates reaching 21%. Other techniques (radioactive seed or radio-occult lesion localization, intraoperative ultrasound, magnetic, radiofrequency and radar localization) have been developed with the aim of overcoming these disadvantages. However, comparative data on the rates of successful lesion removal, negative margins and re-operations are limited. In the majority of studies, the patient’s perspective with regard to discomfort and pain level has not been evaluated. The aim of MELODY (MEthods for LOcalization of Different types of breast lesions) is to evaluate different imaging-guided localization methods with regard to oncological safety, patient-reported outcomes, and surgeon and radiologist satisfaction. Methods: The EUBREAST and the iBRA-NET have initiated the MELODY study to assess breast localization techniques and devices from several perspectives (NCT05559411, http://melody.eubreast.com). MELODY is a prospective intergroup cohort study which enrolls female and male patients requiring breast-conserving surgery and image-guided localization for invasive breast cancer or DCIS. Multiple or bilateral lesions and neoadjuvant chemotherapy are allowed. Primary outcomes are: 1) Intended target lesion and/or marker removal, independent of margin status on final histopathology, and 2) Negative resection margin rates at first surgery. Secondary outcomes are, among others: rates of second surgery and secondary mastectomy, Resection Ratio (defined as actual resection volume divided by the calculated optimum specimen volume), duration of surgery, marker dislocation rates, rates of marker placement or localization failure, comparison of patient-reported outcomes, rates of “lost markers” and diagnostician/radiologist’s and surgeon’s satisfaction as well as the health economic evaluation of the different techniques. Target accrual: 7,416 patients. Enrollment started in January 2023. The study is being conducted in 30 countries and is supported by the Oncoplastic Breast Consortium (OPBC), AWOgyn, AGO-B and SENATURK. Financial support was provided by Endomag, Merit Medical, Sirius Medical and Hologic. Citation Format: Maggie Banys-Paluchowski, Nina Ditsch, Thorsten Kühn, James Harvey, Nuh Zafer Canturk, Neslihan Cabioglu, Tove Filtenborg Tvedskov, Lina Pankratjevaite, Maria Luisa Gasparri, Dawid Murawa, Jai Min Ryu, Oreste Davide Gentilini, Rosa Di Micco, Mah Muneer Khan, Aoife Lowery, Natalia Krawczyk, Steffi Hartmann, Isabel T. Rubio, Antonio J. Esgueva, Jana de Boniface, Andreas Karakatsanis, Rajiv V. Dave, Shelley Potter, Ashutosh Kothari, Walter Paul Weber, Güldeniz Karadeniz Cakmak, Markus Hahn, Michael Patrick Lux, Marjolein Smidt, Bahadir M. Gulluoglu, Michaelis Kontos, Florentina Peintinger, Lia Pamela Rebaza, Maria Antónia Vasconcelos, Mariana Correia, Sarah Nietz, Francois Malherbe, Severine Alran, Khaled Mohammad Abdelwahab, Veronica Yamila Fabiano, Svs Deo, Yazan Masannat, Katharina Jursik, Bilge Aktas Sezen, Meldoy Study Group. MELODY: A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions (EUBREAST-4 / iBRA-NET, NCT 05559411) [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P3-12-16.

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