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

NCT05942105 | Active Not Recruiting

• 1 other identifier: 2776
• Study Type: observational
• Target: 1,064
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Excess breast resection

  6 months

• Surgery time

  6 months

• Hospitalization days

  6 months

• Complications

  6 months

• Reintervention

  6 months

Study Arms (4)

ROLL technique

Radioguided occult lesion localization

Procedure: Breast conservative surgery

MAGNETIC SEED

Magnetic seed localization

Procedure: Breast conservative surgery

WGL technique

Wire guided localization for non-palpable breast lesions

Procedure: Breast conservative surgery

CARBON

Carbon dye localization for non-palpable breast lesions

Procedure: Breast conservative surgery

Interventions

Breast conservative surgery PROCEDURE

Breast conservative surgery after non-palpable lesion localization

CARBON; MAGNETIC SEED; ROLL technique; WGL technique

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients with non-palpable breast lesion candidated for conservative surgery

You may qualify if:

• 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).

You may not qualify if:

• 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.

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

Condition Hierarchy (Ancestors)

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

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: May 31, 2023
• Primary Completion: March 30, 2025
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-05

Locations

IT (1)