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

NCT ID: NCT05942118

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 262 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2028-05-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ROLL

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.

Breast conservative surgery

Intervention Type: PROCEDURE

Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization

SEED

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

Breast conservative surgery

Intervention Type: PROCEDURE

Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization

Interventions

Breast conservative surgery

Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Fabio Corsi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Fabio Corsi, Professor

Role: primary

fabio.corsi@icsmaugeri.it

0382592272

Sara Albasini, MsC

Role: backup

sara.albasini@icsmaugeri.it

3497378405

Other Identifiers

2778

Identifier Type: -

Identifier Source: org_study_id