Clinical trial · Observational
RADIOSO MILAN I (RADar Reflector localisatiOn-SCOUT for carcinOma Mammae, the MILAN IEO Experience I)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Occult Breast Carcinoma | Occult Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCOUT® Radar occult breast lesion Localization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Rate of successful positioning of the reflector
- timeFrame
- 1 week
- description
- Percentage of reflectors successfull positioned
- measure
- Rate of successful localization of the reflector
- timeFrame
- 6 months
- description
- Percentage of reflectors successfull localized
- measure
- Rate of successful recovery of the reflector
- timeFrame
- 6 months
- description
- Percentage of reflectors successfull recovered
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGianmatteo 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. PMID 41721162