Comparing ROLL and Magnetic Seed Techniques for Breast Lesion Localization
A Retrospective Multicentric Clinical Study Comparing Radioguided Occult Lesion Localization (ROLL) and Magnetic Seed in the Intraoperative Localization of Non-palpable Breast Lesions During Breast Conservative Surgery.
This study is testing whether a new way to locate breast tumors using ROLL or magnetic seeds helps patients have better surgery outcomes and less chance of the cancer coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardia) |
| Trial ID | NCT05942092 on ClinicalTrials.gov |
What this trial studies
This study compares two techniques, ROLL and magnetic seed localization, for preoperative localization of non-palpable breast lesions in patients undergoing breast-conserving surgery. The aim is to determine which method provides better outcomes in terms of complete tumor resection and minimizing the risk of local recurrence. By evaluating the effectiveness of these techniques, the study seeks to enhance surgical precision and patient comfort during the procedure.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 85 with non-palpable breast lesions who are scheduled for breast-conserving surgery.
Not a fit: Patients with benign lesions or those who have undergone breast tumor localization with clips for neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and reduce the need for additional surgeries in breast cancer patients.
How similar studies have performed: While wire guided localization has been the gold standard, this study explores newer techniques, indicating a novel approach in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients between 18 and 85 years who underwent to breast conservative surgery for non-palpable occult breast lesions; * Intraoperative localization of breast lesion with ROLL or magnetic seed; * Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5). Exclusion Criteria: * B2 or C2 at preoperative needle breast biopsy or fine needle breast aspiration. * Breast tumor localization with clip for 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.