NCT05942118

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

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 262 (estimated)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Breast conservative surgery	Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization

Timeline

• Start date: 2023-05-31
• Primary completion: 2026-05-31
• Completion: 2028-05-31
• First posted: 2023-07-12
• Last updated: 2025-05-20

Locations

1 site across 1 country: Italy