ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques.

Recruiting

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

• Registration Number: NCT05942092
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief Summary

Nowadays, Breast Conservative Surgery (BCS) is the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of impalpable breast lesion detection rates. These patients are often eligible for BCS and an accurate preoperative localization technique for the detection of the lesion is required in order to guarantee a safe surgical excision.

The primary goal of BCS is to obtain a complete resection of the tumor with disease-free surgical margins. The presence of tumor on surgical margins on postoperative histological examination of the specimen increases the risk of local recurrence and it requires a surgical re-excision. For all these reasons different techniques for localization of occult breast lesions have been developed over time. Since '70s, the wire guided localization (WGL) technique has represented the gold standard technique; however, it has several limitations such as wire migration or fracture and patient's referred discomfort related to wire placement. Other techniques have been proposed such as the ROLL and magnetic seeds.

The ROLL consists of the injection of a radioactive substance into the breast lesion and the localization during surgery is allowed by using a handheld gamma probe. Limitations of this technique are represented by the need of radioactive injection the day before surgery with subsequent longer hospitalizations and the possible spread of the radioactive substance into breast tissue leading to larger resections.

The latest technological evolution is represented by magnetic seeds, small devices deployed into the lesion even up to more than 30 days before surgery and identified with a specific magnetic probe during surgery.

Currently there are several studies of comparison between the WGL and the more modern techniques. All of these data claim the effectiveness of the new "wire-free" methodics ensuring a safe surgical resection with tumor-free margins and, in some cases, a better aesthetic result.

Studies of comparison between the modern techniques are limited. There is no scientific evidence of the superiority of magnetic seeds compared to ROLL.

The aim of this retrospective study is to compare ROLL with magnetic seed to assess their efficacy in the localization of non-palpable breast lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-26
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

• Female patients between 18 and 85 years who underwent to breast conservative surgery for non-palpable occult breast lesions;
• Intraoperative localization of breast lesion with ROLL or magnetic seed;
• Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5).

Exclusion Criteria

• B2 or C2 at preoperative needle breast biopsy or fine needle breast aspiration.
• Breast tumor localization with clip for neoadjuvant chemotherapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ROLL	Breast conserving surgery	-
SEED	Breast conserving surgery	-

Primary Outcome Measures

Name	Time	Method
Free-surgical margins	6 months	Number of surgical procedures in which surgical margins are tumor 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
Hospitalization's days	6 months	Number of hospitalization's days
Excess breast resection	6 months	Excess breast resection calculated by the "calculated resection ratio" (CRR=total resection volume/optimal resection volume)
Complications	6 months	Complications occurred after biopsy or surgery
Reintervention	6 months	Reintervention rates
Surgery time	6 months	Surgery duration

Trial Locations

Locations (1)

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