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

NCT05942092 | Active Not Recruiting

• 1 other identifier: 2755
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

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 tumor disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).

  6 months

Secondary Outcomes (6)

• Excess breast resection

  6 months

• Surgery time

  6 months

• Hospitalization's days

  6 months

• Complications

  6 months

• Reintervention

  6 months

Study Arms (2)

ROLL

Procedure: Breast conserving surgery

SEED

Procedure: Breast conserving surgery

Interventions

Breast conserving surgery PROCEDURE

Breast conserving surgery after lesion's localization with ROLL or magnetic seed

ROLL; SEED

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Breast cancer is gender based
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer women with non-palpable lesions

You may qualify if:

• 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).

You may not qualify if:

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

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Design

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

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 12, 2023
• Study Start: April 26, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 23, 2026

Record last verified: 2025-05

Locations

IT (1)