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Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
Sponsor: Istituti Clinici Scientifici Maugeri SpA
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
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