Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study. (SEED02)

A 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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Breast conservative surgery

• Study Type: Observational
• Enrollment (Estimated): 262

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • Recruiting
      • Istituti Clinici Scientifici Maugeri SpA
      • Contact: Fabio Corsi, Professor; Phone Number: 0382592272; Email: fabio.corsi@icsmaugeri.it
      • Contact: Sara Albasini, MsC; Phone Number: 3497378405; Email: sara.albasini@icsmaugeri.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Breast cancer patients with non-palpable lesions candidated for surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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	Procedure: Breast conservative surgery; Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Non-palpable breast lesion
• Other Study ID Numbers: 2778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No