Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Breast conservative surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ROLL<br>Prior to surgery, an ultrasound-guided localization will be performed and albumin marked with Technetium 99m will be injected close to the tumor and in the subareolar area. During surgery, a specific probe will be used to locate the lesion and sentinel lymph node. | Procedure: Breast conservative surgery<br>* Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization<br>|
| SEED<br>During diagnostic biopsy or prior to surgery, a magnetic clip will be placed in the breast lesion; during surgery, localization will be performed using a specific probe, while sentinel lymph node localisation, when needed, will be performed even with indocyanine green dye (ICG) or methylene blue dye | Procedure: Breast conservative surgery<br>* Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free-surgical margins | 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). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess breast resection | Excess breast resection calculated by the calculated resection ratio (CRR) as follow: CRR = total resection volume/optimal resection volume | 3 years | 
| Surgery Time | Surgery duration (hours) | 3 years | 
| Hospitalization days | Number of hospitalization's days | 3 years | 
| Complications | Complications occurred after biopsy or surgery | 3 years | 
| Reintervention | Reintervention rates | 3 years | 
| Cost-effectiveness analysis | Cost-effectiveness analysis in different subgroups | 3 years | 
| Follow up | 5-years follow-up outcomes | 5 years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-palpable breast lesion