Using radar technology to locate undetectable breast lesions for surgery
RADIOSO MILAN I (RADar Reflector localisatiOn-SCOUT for carcinOma Mammae, the MILAN IEO Experience I)
This study is testing a new radar system to help doctors find hidden breast lesions during surgery for patients with breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT05963464 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with clinically undetectable breast lesions who are candidates for breast-conserving surgery. It utilizes the SCOUT® Radar occult breast lesion Localization system, which employs an implantable reflector and a detector to guide surgical excision in real-time without the use of radioactive materials. The study aims to evaluate the effectiveness of this method in successfully positioning and recovering the reflector in a cohort of 300 patients at the European Institute of Oncology. The findings could enhance surgical planning and treatment options for breast cancer patients.
Who should consider this trial
Good fit: Ideal candidates include female patients aged 18 to 90 with nonpalpable breast lesions referred for conservative surgery.
Not a fit: Patients with known allergies to materials similar to those in the SCOUT components or those with conditions that may complicate study compliance will not benefit.
Why it matters
Potential benefit: If successful, this approach could improve the accuracy of breast cancer surgeries and potentially lead to better patient outcomes.
How similar studies have performed: While similar localization techniques have been used, this specific approach with the SCOUT system is relatively novel and under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Gianmatteo Pagani, MD — European Institute of Oncology
- Study coordinator: Gianmatteo Pagani, MD
- Email: gianmatteo.pagani@ieo.it
- Phone: +390257489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.