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

Recruiting

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

• Registration Number: NCT05942105
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Status Verified: 2024-05
• Primary Completion: 2025-03-30
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1064

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ROLL technique	Breast conservative surgery	Radioguided occult lesion localization
WGL technique	Breast conservative surgery	Wire guided localization for non-palpable breast lesions
MAGNETIC SEED	Breast conservative surgery	Magnetic seed localization
CARBON	Breast conservative surgery	Carbon dye localization for non-palpable breast lesions

Primary Outcome Measures

Name	Time	Method
Free-surgical margins	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Hospitalization days	6 months	Number of hospitalization days
Complications	6 months	Complications (after biopsy or surgery)
Follow up	5 years after enrollment	5-years follow-up outcomes
Reintervention	6 months	Reintervention rates
Surgery time	6 months	Surgery duration
Excess breast resection	6 months	Excess breast resection calculated by the "calculated resection ratio" (CRR=total resection volume/optimal resection volume)

Trial Locations

Locations (1)

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