Results of a phase I, non-randomized study evaluating a Magnetic Occult Lesion Localization Instrument (MOLLI) for excision of non-palpable breast lesions

• Published in: Breast cancer research and treatment 2020-02, Vol.179 (3), p.671-676
• Main Authors: Look Hong, Nicole, Wright, Frances C., Semple, Mark, Nicolae, Alexandru M., Ravi, Ananth
• Format: Article
• Language: English
• Subjects: Breast; Breast cancer; Cancer research; Clinical Trial; Lesions; Localization; Lumpectomy; Medicine; Medicine & Public Health; Oncology
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1007/s10549-019-05499-z

Purpose Magnetic Occult Lesion Localization Instrument (MOLLI) is a wireless, non-radioactive alternative for non-palpable breast lesion localization. The primary objective of this first-in-human study was to evaluate the clinical feasibility of using MOLLI for intraoperative localization of non-palpable breast lesions. Methods Twenty women with non-palpable breast lesions at a single institution received a lumpectomy using the MOLLI guidance system. Patients were co-localized with magnetic and radioactive markers up to 7 days before excision by a dedicated breast radiologist under sonographic guidance. Both markers were localized intraoperatively using dedicated hand-held probes. The primary outcome was successful excision of the magnetic marker, confirmed radiographically and pathologically. Demographic data, margin positivity, and re-excision rates were collected. Surgical oncologists, radiologists, and pathology staff were surveyed for user satisfaction. Results Post-radiological analysis: Post-implant mammograms verified that 17/20 markers were placed directly in the lesion center. Radiologists reported that all marker implantations procedures were “easy” or “very easy” following a single training session. Post-surgical analysis: All MOLLI markers were successfully removed with the specimen during surgical excision. In all cases, surgeons ranked the MOLLI guidance system as “very easy” for lesion localization. Pathologic analysis: All patients had negative margins. All anatomic pathology staff ranked the MOLLI system as “very easy” to localize markers. Conclusions The MOLLI guidance system is a reliable and accurate method for intraoperative localization of non-palpable breast lesions. Further evaluation of the MOLLI system in studies against current standards of care is required to demonstrate system cost-effectiveness and improved patient-reported outcomes.