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NCT Number: NCT05942105

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast conservative surgery

Procedure

Breast conservative surgery after non-palpable lesion localization

Primary outcomes

  1. Free-surgical margins

    Time frame: 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 outcomes

  1. Excess breast resection

    Time frame: 6 months

    Excess breast resection calculated by the "calculated resection ratio" (CRR=total resection volume/optimal resection volume)

  2. Surgery time

    Time frame: 6 months

    Surgery duration

  3. Hospitalization days

    Time frame: 6 months

    Number of hospitalization days

  4. Complications

    Time frame: 6 months

    Complications (after biopsy or surgery)

  5. Reintervention

    Time frame: 6 months

    Reintervention rates

  6. Follow up

    Time frame: 5 years after enrollment

    5-years follow-up outcomes

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

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

Acronym: Localization01

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Jul 12, 2023
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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