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RECRUITING
NCT05942118

Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.

Sponsor: Istituti Clinici Scientifici Maugeri SpA

View on ClinicalTrials.gov

Summary

Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.

Official title: A Monocentric, Prospective, Randomized Clinical Study Comparing ROLL (Radioguided Occult Lesion Localization) With Magnetic Markers for Preoperative Localization of Non-palpable Breast Lesions in Patients Undergoing Breast Conservative Surgery.

Key Details

Gender

FEMALE

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

262

Start Date

2023-05-31

Completion Date

2028-05-31

Last Updated

2025-05-20

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Breast conservative surgery

Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization

Locations (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, Italy