Breast Cancer
Conditions
Keywords
Non-palpable breast lesion
Brief summary
Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. Scientific evidence supports the efficacy of the new wire-free techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.
Interventions
PROCEDUREBreast conservative surgery
Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization
Sponsors
Istituti Clinici Scientifici Maugeri SpA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free-surgical margins | 3 years | Number of surgical procedures in which surgical margins are disease-free (no ink on tumor for invasive cancer and margin of 2 mm for in situ-carcinoma). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reintervention | 3 years | Reintervention rates |
| Cost-effectiveness analysis | 3 years | Cost-effectiveness analysis in different subgroups |
| Follow up | 5 years after enrollment | 5-years follow-up outcomes |
| Complications | 3 years | Complications occurred after biopsy or surgery |
| Surgery Time | 3 years | Surgery duration (hours) |
| Hospitalization days | 3 years | Number of hospitalization's days |
| Excess breast resection | 3 years | Excess breast resection calculated by the calculated resection ratio (CRR) as follow: CRR = total resection volume/optimal resection volume |
Countries
Italy
Outcome results
None listed