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

Breast Cancer Clinical Trial

— Localization01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942105
• Other study ID #: 2776
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1064
• Est. completion date: September 30, 2028
• Est. primary completion date: March 30, 2025
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Breast conservative surgery
Breast conservative surgery after non-palpable lesion localization

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri SpA	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

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