UnknownNot Applicable

RADIOSO MILAN I (RADar Reflector localisatiOn-SCOUT for carcinOma Mammae, the MILAN IEO Experience I)

Italy300 participantsStarted 2023-02-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 90 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of successful positioning of the reflector

Timeframe: 1 week

Rate of successful localization of the reflector

Timeframe: 6 months

Rate of successful recovery of the reflector

Timeframe: 6 months

Trial details

NCT IDNCT05963464

SponsorEuropean Institute of Oncology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

Contact for this trial

Gianmatteo Pagani, MD

+390257489 gianmatteo.pagani@ieo.it

View on ClinicalTrials.gov More Breast Cancer trials