NCT05942105: Localization01

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

Active, enrolled Last updated 2 September 2025

What this trial tests

trial testing Breast conservative surgery in Breast Cancer in 1,064 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 May 2023

Primary endpoint
30 March 2025

30 September 2028

Quick facts

Lead sponsor	Istituti Clinici Scientifici Maugeri SpA
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,064
Start date	31 May 2023
Primary completion	30 March 2025
Estimated completion	30 September 2028
Sites	1 location across Italy

Drugs / interventions tested

• Breast conservative surgery

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Who can join

Adults 18 to 85, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Surgeon seniority and performance in breast-conserving surgery for non-palpable lesions: evidence from a multicenter study.
   Corsi F, Gasparri ML, Albasini S, Pelizzola M, et al · · 2026 · cited 1× · PMID 41689895 · DOI 10.1016/j.breast.2026.104736
2. Comparative effectiveness of preoperative localization techniques for non-palpable breast lesions: multicentre real-world study.
   Corsi F, Albasini S, Pelizzola M, Morasso C, et al · · 2025 · PMID 41504703 · DOI 10.1093/bjsopen/zraf153