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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCOUT® Radar occult breast lesion Localization | Device | The SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive micro-impulses to guide surgical excision in real time. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosis of nonpalpable breast lesion or lymph nodes requiring conservative surgical excision.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianmatteo Pagani, MD | Contact | +390257489 | 308 | gianmatteo.pagani@ieo.it |
| Claudia Sangalli, MSc | Contact | +390257489 | 840 | claudia.sangalli@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Gianmatteo Pagani, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41721162 | Derived | Gianmatteo P, Andrea P, Erica AA, Antuono L, Luca N, Enrico C, Lavinia TL, Francesco C, Claudia S, Paolo V, Viviana G. RADar Reflector LocalisatIOn-SCOUT(R) for CarcinOma Mammae, a Prospective Observational Study Sharing Clinical Experience at the European Institute of Oncology in Milan: RADIOSO Milan Trial. Ann Surg Oncol. 2026 Jun;33(6):5513-5523. doi: 10.1245/s10434-026-19212-0. Epub 2026 Feb 20. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |