Different Localization Techniques for Non-palpable Breast Lesions Comparison: a Retrospective and Multicentric Clinical Study (Localization01)

A Retrospective Multicentric Clinical Study Comparing Different Techniques for Intraoperative Localization of Non-palpable Breast Lesions During Breast Conservative Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Breast conservative surgery

• Study Type: Observational
• Enrollment (Estimated): 1064

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Istituti Clinici Scientifici Maugeri SpA

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 breast lesion candidated for conservative surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ROLL technique; Radioguided occult lesion localization	Procedure: Breast conservative surgery; Breast conservative surgery after non-palpable lesion localization
MAGNETIC SEED; Magnetic seed localization	Procedure: Breast conservative surgery; Breast conservative surgery after non-palpable lesion localization
WGL technique; Wire guided localization for non-palpable breast lesions	Procedure: Breast conservative surgery; Breast conservative surgery after non-palpable lesion localization
CARBON; Carbon dye localization for non-palpable breast lesions	Procedure: Breast conservative surgery; Breast conservative surgery after non-palpable lesion 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)	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): March 30, 2025
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2776

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