Recruiting

SEED02A 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.

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

From 18 to 85 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2023
See protocol details

Summary

Principal SponsorIstituti Clinici Scientifici Maugeri SpA
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 31, 2023

Actual date on which the first participant was enrolled.

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 TitleA 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.
NCT05942118
Principal SponsorIstituti Clinici Scientifici Maugeri SpA
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

262 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

5 inclusion criteria required to participate
Female;
Non-palpable breast lesions;
Indication to lesion's surgical excision (lumpectomy, quadrantectomy)
Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5);
Show More Criteria
3 exclusion criteria prevent from participating
Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2);
Clinically palpable breast lesion;
Breast lesion localization for planned neoadjuvant chemotherapy.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Istituti Clinici Scientifici Maugeri SpA

Pavia, ItalyOpen Istituti Clinici Scientifici Maugeri SpA in Google Maps
Recruiting
One Study Center