SCOUT® Radar Localization in Nonpalpable Breast Lesions

Study Overview
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Brief Summary
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This is a monocentric prospective observational study for patients with clinical undetectable breast lesions and indications to breast conserving surgery for histological characterization. The SCOUT® Radar occult breast lesion Localization (SRL) consists of an implantable reflector, a detector handpiece and a console and it uses non-radioactive micro-impulses to guide surgical excision in real time. The study describes the experience with 300 patients at the European Institute of Oncology. The primary endpoints of the study are the rates of successful positioning, localization and recovery of the reflector SRL.

Detailed Description
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It has been estimated that 31,8% of breast cancer patients undergo pre-operational lesion localization. Of them, 19% have been previously administered neoadjuvant chemotherapy (NACT). Based on retrospective data, NACT administration is believed to steadily increase by 1,3%, each year. The IEO Breast Division Program aims at improving the treatment and planning options available to patients referred for radio guided breast surgery. At IEO, ROLL remains the standard of care. From its inception 25 year ago to the present day,the investigators have gained significant expertise and now perform more than 1000 procedures per year. The investigators believe that SRL (SCOUT® Radar occult breast lesion Localization) could be added to the procedure of reference in the following cases, still under investigation, where it seems to present some advantages when compared to ROLL: Long-term positioning of the reflector, as in the case of patients undergoing neoadjuvant treatment Reflector placement in malignant lymphadenopathy prior to neoadjuvant chemotherapy Placement of multiple reflectors, or use of both SRL and ROLL in patients with multifocal or multicentric neoplasia referred for conservative surgery BI-RADS 5 patients suspected for ductal carcinoma in situ (DCIS) and eligible for conservative surgery, could undergo reflector placement after vacuum-assisted breast biopsy (VABB) and also be scheduled for Monday morning surgery Placement of the reflector using MR-compatible introducer needles

Official Title
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SCOUT® Radar Localization: Experience With 300 Patients at the European Institute of Oncology

Conditions
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Breast Cancer, Occult Breast Carcinoma

Intervention / Treatment
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* Device: SCOUT® Radar occult breast lesion Localization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of nonpalpable breast or lymph nodes Patients referred to IEO for breast surgery Patients between 18 and 90 years old Female patients Conservative surgery Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study Exclusion Criteria: Patients known or suspected to be allergic to materials similar to those in the SAVI SCOUT components (nickel) Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

| Intervention/Treatment |
| --- |
|Device: SCOUT® Radar occult breast lesion Localization|The SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive micro-impulses to guide surgical excision in real time.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful positioning of the reflector | Percentage of reflectors successfull positioned | 1 week | 
| Rate of successful localization of the reflector | Percentage of reflectors successfull localized | 6 months | 
| Rate of successful recovery of the reflector | Percentage of reflectors successfull recovered | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cases with negative margins | percentage of cases with negative margins | 6 months | 
| Rate of cases that have required a second excision | Percentage of cases that have required a second excision | 6 months |