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

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Breast conservative surgery

• Registration Number: NCT05942118
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 262

Inclusion Criteria

• 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);
• Written informed consent.

Exclusion Criteria

• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ROLL	Breast conservative surgery	Prior to surgery, an ultrasound-guided localization will be performed and albumin marked with Technetium 99m will be injected close to the tumor and in the subareolar area. During surgery, a specific probe will be used to locate the lesion and sentinel lymph node.
SEED	Breast conservative surgery	During diagnostic biopsy or prior to surgery, a magnetic clip will be placed in the breast lesion; during surgery, localization will be performed using a specific probe, while sentinel lymph node localisation, when needed, will be performed even with indocyanine green dye (ICG) or methylene blue dye

Primary Outcome Measures

Name	Time	Method
Free-surgical margins	3 years	Number of surgical procedures in which surgical margins are disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).

Secondary Outcome Measures

Name	Time	Method
Follow up	5 years after enrollment	5-years follow-up outcomes
Surgery Time	3 years	Surgery duration (hours)
Hospitalization days	3 years	Number of hospitalization's days
Complications	3 years	Complications occurred after biopsy or surgery
Excess breast resection	3 years	Excess breast resection calculated by the "calculated resection ratio" (CRR) as follow: CRR = total resection volume/optimal resection volume
Cost-effectiveness analysis	3 years	Cost-effectiveness analysis in different subgroups
Reintervention	3 years	Reintervention rates

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri SpA; 🇮🇹 Pavia, Lombardia, Italy