Different Localization Techniques for Non-palpable Breast Lesions Comparison: a Retrospective and Multicentric Clinical Study

NCT ID: NCT05942105

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1064 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2028-09-30

Brief Summary

Breast conservative surgery (BCS) is nowadays the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of non-palpable 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 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 non-palpable breast lesions have been developed over time. Since '70s the wire guided localization (WGL) technique has represented the gold standard; however it has several limitations such as wire migration or fracture and patient referred discomfort related to wire placement. Over time, other techniques have been proposed, such as the radioguided occult lesion localization (ROLL), radioactive and magnetic seeds, carbon dye and ultrasound-guided preoperative localization.

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 a technique over the other. A multicentric Italian survey demonstrated that the most used localization techniques nowadays are the WGL, ROLL, the magnetic seed and the carbon dye.

The aim of this retrospective study is to compare these techniques to assess their efficacy in the localization of non-palpable breast lesions.

Conditions

Breast Cancer

Study Design

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

Study Groups

ROLL technique

Radioguided occult lesion localization

Breast conservative surgery

Intervention Type: PROCEDURE

Breast conservative surgery after non-palpable lesion localization

MAGNETIC SEED

Magnetic seed localization

Breast conservative surgery

Intervention Type: PROCEDURE

Breast conservative surgery after non-palpable lesion localization

WGL technique

Wire guided localization for non-palpable breast lesions

Breast conservative surgery

Intervention Type: PROCEDURE

Breast conservative surgery after non-palpable lesion localization

CARBON

Carbon dye localization for non-palpable breast lesions

Breast conservative surgery

Intervention Type: PROCEDURE

Breast conservative surgery after non-palpable lesion localization

Interventions

Breast conservative surgery

Breast conservative surgery after non-palpable lesion localization

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female sex;
• Patients who underwent breast conservative surgery for non-palpable occult breast lesions;
• Intraoperative localization of breast lesion with WGL, ROLL, magnetic seed, carbon dye;
• Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5).

Exclusion Criteria

• Diagnosis of benign breast lesion, both on preoperative needle breast biopsy (B2) or on fine needle breast aspiration (C2);
• Clinically palpable breast lesion;
• Localization of a non-palpable lesion through two or more different techniques;
• Breast tumor localization with clip in patients who underwent 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

Countries

Italy

Other Identifiers

2776

Identifier Type: -

Identifier Source: org_study_id