Comparing two techniques for locating non-palpable breast lesions before surgery
A Monocentric, Prospective, Randomized Clinical Study Comparing ROLL (Radioguided Occult Lesion Localization) With Magnetic Markers for Preoperative Localization of Non-palpable Breast Lesions in Patients Undergoing Breast Conservative Surgery.
This study is testing two different methods for finding hard-to-locate breast lesions before surgery to see which one works better and is more comfortable for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 262 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT05942118 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two modern localization techniques, ROLL and magnetic seed localization, for non-palpable breast lesions prior to surgical excision. Both methods are evaluated for their effectiveness in ensuring safe surgical resection while minimizing patient discomfort and logistical challenges associated with traditional wire-guided localization. The study is randomized, allowing for a direct comparison of the two techniques to determine if one is superior in terms of efficacy. The findings could provide valuable insights into the best practices for preoperative localization in breast cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are females with non-palpable breast lesions requiring surgical excision and a preoperative diagnosis indicating borderline or malignant lesions.
Not a fit: Patients with benign lesions or clinically palpable breast lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and patient comfort for women undergoing surgery for non-palpable breast lesions.
How similar studies have performed: While there is limited data on the comparative effectiveness of ROLL versus magnetic seed localization, previous studies have shown promise for modern localization techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female; * Non-palpable breast lesions; * Indication to lesion's surgical excision (lumpectomy, quadrantectomy) * Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5); * Written informed consent. Exclusion Criteria: * Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2); * Clinically palpable breast lesion; * Breast lesion localization for planned neoadjuvant chemotherapy.
Where this trial is running
Pavia, Lombardy
- Istituti Clinici Scientifici Maugeri SpA — Pavia, Lombardy, 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.