Evidence map›Paper›PMID 41936682›Full record

Trial reportAnnals of surgical oncology2026

A Prospective Randomized Trial Comparing Radioguided Occult Lesion Localization (ROLL) and Magnetic Seed Localization for the Localization of Nonpalpable Breast Lesions: Analysis of Surgical Outcomes, Patient's Perception, and Costs.

Fabio Corsi, Matilde Pelizzola, Daniela Bossi, Valentina Zanella, Silvana Quaglini, Federico Sottotetti, Sara Albasini, Carlo Morasso

Abstract readRandomized Controlled TrialComparative StudyEquivalence Trial
In one paragraph

Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

8 authors.

Fabio CorsiDepartment of Biomedical and Clinical Sciences, University of Milan, Milan, Italy. fabio.corsi@icsmaugeri.it.
Matilde PelizzolaGeneral Surgery Residency Program, University of Milan, Milan, Italy.
Daniela BossiBreast Unit, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.
Valentina ZanellaGeneral Surgery Residency Program, University of Milan, Milan, Italy.
Silvana QuagliniDepartment of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.
Federico SottotettiMedical Oncology Unit, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.
Sara AlbasiniBreast Unit, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.
Carlo MorassoLaboratory of Nanomedicine, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.

Funding

Ministero della Salute Ricerca corrente
6 · The paper itself

Abstract

backgroudAccurate localization of nonpalpable breast lesions in breast-conserving surgery (BCS) is essential for achieving oncological radicality, preserving cosmetic outcomes, and reducing reinterventions for positive margins. Radioguided occult lesion localization (ROLL) and magnetic seed localization (MSL) are established alternatives to wire-guided methods, but comparative evidence remains limited.

methodsThis prospective, single-centre, randomized clinical trial evaluated the noninferiority of MSL compared with ROLL in achieving negative surgical margins, assessed surgical, organizational, and patient-reported outcomes, and included a costs analysis. A total of 260 women with nonpalpable breast lesions suitable for BCS were enrolled between June 2023 and July 2025 and randomized 1:1 to ROLL or MSL. The primary endpoint was margin negativity. Secondary endpoints included calculated resection ratio (CRR), operative time, complications, hospital stay, reoperation rate, and EQ-5D-5L patient-reported outcomes.

resultsNegative margins were achieved in 97.7% of ROLL and 93.1% of MSL cases (p = 0.14), confirming MSL noninferiority. Median CRR was identical (1.7, p = 0.61). Overall complication rates were comparable (6.2%-MSL vs. 4.7%-ROLL, p = 0.59), although postlocalization hematoma was more frequent with MSL (17% vs. 7%, p = 0.01). Hospital stay was significantly shorter with MSL (1 vs. 2 days, p = 0.001). Operative times were similar, and surgeon experience did not influence margin status, although attendings achieved lower CRR with ROLL. EQ-5D-5L scores were comparable except for "usual activities" dimension, which favoured ROLL.

conclusionsMSL was noninferior to ROLL, with comparable safety and patient-reported outcomes. Magnetic seed localization was found to be costs-saving across all analysed subgroups. Our results show that MSL is an effective alternative for lesion localization in BCS.

Indexed as

Breast NeoplasmsMastectomy, SegmentalSurgery, Computer-AssistedAdultAgedFemaleFollow-Up StudiesHumansMargins of ExcisionMiddle AgedPatient Reported Outcome MeasuresPrognosisProspective StudiesRadiopharmaceuticalsRadiopharmaceuticalsBreast-conserving surgeryMagnetic seed localizationNon-palpable breast lesionsPatient-reported outcomesRadioguided occult lesion localizationRandomized trialSurgical outcomes

Identifiers

PMID41936682
PMCPMC13242391

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.