Actively Recruiting
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2025-05-20
262
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Non-palpable breast lesions
- Indication for surgical removal of the lesion (lumpectomy or quadrantectomy)
- Preoperative diagnosis of borderline or malignant lesion by biopsy or cytology
- Provided written informed consent
You will not qualify if you...
- Benign lesion diagnosed by preoperative biopsy or fine needle aspiration
- Breast lesion that can be felt on physical exam
- Breast lesion planned for localization before neoadjuvant chemotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, Italy, 27100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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