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Trial Title:
Different Localization Techniques for Non-palpable Breast Lesions Comparison: a Retrospective and Multicentric Clinical Study
NCT ID:
NCT05942105
Condition:
Breast Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Breast conservative surgery
Description:
Breast conservative surgery after non-palpable lesion localization
Arm group label:
CARBON
Arm group label:
MAGNETIC SEED
Arm group label:
ROLL technique
Arm group label:
WGL technique
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.
Criteria for eligibility:
Study pop:
Breast cancer patients with non-palpable breast lesion candidated for conservative
surgery
Sampling method:
Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
85 Years
Locations:
Facility:
Name:
Istituti Clinici Scientifici Maugeri SpA
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Corsi, Professor
Phone:
0382592272
Email:
fabio.corsi@icsmaugeri.it
Contact backup:
Last name:
Sara Albasini, MsC
Phone:
3497378405
Email:
sara.albasini@icsmaugeri.it
Start date:
May 31, 2023
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Istituti Clinici Scientifici Maugeri SpA
Agency class:
Other
Source:
Istituti Clinici Scientifici Maugeri SpA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05942105
