Clinical trial NCT05942105: Different Localization Techniques for Non-palpable Breast Lesions Comparison: a Retrospective and Multicentric Clinical Study
Official title: A Retrospective Multicentric Clinical Study Comparing Different Techniques for Intraoperative Localization of Non-palpable Breast Lesions During Breast Conservative Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 1064
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients with non-palpable breast lesion candidated for conservative surgery

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Free-surgical margins
timeFrame: 6 months
Secondary outcomes:
measure: Excess breast resection
timeFrame: 6 months
measure: Surgery time
timeFrame: 6 months
measure: Hospitalization days
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
measure: Reintervention
timeFrame: 6 months
measure: Follow up
timeFrame: 5 years after enrollment
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri SpA
state: Lombardia
Study officials:
References: