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

NCT05942118 | Active Not Recruiting

• 1 other identifier: 2778
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

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

Keywords

Non-palpable breast lesion

Outcome Measures

Primary Outcomes (1)

• Free-surgical margins

  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).

  3 years

Secondary Outcomes (7)

• Excess breast resection

  3 years

• Surgery Time

  3 years

• Hospitalization days

  3 years

• Complications

  3 years

• Reintervention

  3 years

Study Arms (2)

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.

Procedure: Breast conservative surgery

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

Procedure: Breast conservative surgery

Interventions

Breast conservative surgery PROCEDURE

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

ROLL; SEED

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients with non-palpable lesions candidated for surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 12, 2023
• Study Start: May 31, 2023
• Primary Completion: May 31, 2026
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)