Comparing techniques for locating non-palpable breast lesions before surgery
A Retrospective Multicentric Clinical Study Comparing Different Techniques for Intraoperative Localization of Non-palpable Breast Lesions During Breast Conservative Surgery
Istituti Clinici Scientifici Maugeri SpA · NCT05942105
This study is testing different ways to find small breast tumors that can’t be felt before surgery to see which method works best for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1064 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardia) |
| Trial ID | NCT05942105 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates different localization techniques for non-palpable breast lesions in patients undergoing breast conservative surgery. It focuses on comparing the effectiveness of wire guided localization, radioactive seed localization, and carbon dye methods to ensure accurate detection and complete resection of tumors. The study aims to identify the best approach to minimize the risk of local recurrence and the need for additional surgeries. By analyzing data from multiple centers, it seeks to provide insights into the most effective preoperative strategies for these patients.
Who should consider this trial
Good fit: Ideal candidates are females who have undergone breast conservative surgery for non-palpable breast lesions with specific histological diagnoses.
Not a fit: Patients with benign breast lesions or those with clinically palpable lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and reduce the need for re-excision in breast cancer patients.
How similar studies have performed: Previous studies have shown varying success with localization techniques, but this study aims to provide a comprehensive comparison of established methods.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pavia, Lombardia
- Istituti Clinici Scientifici Maugeri SpA — Pavia, Lombardia, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer