Breast CancerRADIOSONCT05963464
RADIOSO MILAN I (RADar Reflector localisatiOn-SCOUT for carcinOma Mammae, the MILAN IEO Experience I)
An observational study of Breast Cancer and Occult Breast Carcinoma, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This is a monocentric prospective observational study for patients with clinical undetectable breast lesions and indications to breast conserving surgery for histological characterization. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer, Occult Breast Carcinoma
- What is being tested?
- SCOUT® Radar occult breast lesion Localization
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of nonpalpable breast lesion or lymph nodes requiring conservative surgical excision.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Pagani Gianmatteo, MD, gianmatteo.pagani@ieo.it
About this study
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.
Read the detailed description
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
- Conditions
- Breast Cancer, Occult Breast Carcinoma
- Being tested
- SCOUT® Radar occult breast lesion Localization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCOUT® Radar occult breast lesion LocalizationDevice
The SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive micro-impulses to guide surgical excision in real time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful positioning of the reflector
Percentage of reflectors successfull positioned
Measured: 1 week
Rate of successful localization of the reflector
Percentage of reflectors successfull localized
Measured: 6 months
Rate of successful recovery of the reflector
Percentage of reflectors successfull recovered
Measured: 6 months
Secondary outcomes (2)
Rate of cases with negative margins
percentage of cases with negative margins
Measured: 6 months
Rate of cases that have required a second excision
Percentage of cases that have required a second excision
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianmatteo Pagani, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963464
- Sponsor's protocol ID
- IEO 1911/
- Acronym
- RADIOSO
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41721162
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIOSO MILAN I (RADar Reflector localisatiOn-SCOUT for carcinOma Mammae, the MILAN IEO Experience I)
- ClinicalTrials.gov ID
- NCT05963464
- Acronym / sponsor ID
- RADIOSO / IEO 1911/
- Conditions
- Breast Cancer, Occult Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of nonpalpable breast lesion or lymph nodes requiring conservative surgical excision.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCOUT® Radar occult breast lesion LocalizationThe SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive micro-impulses to guide surgical excision in real time. | Device | – |
Primary outcome
Rate of successful positioning of the reflector
Time frame: 1 week
Percentage of reflectors successfull positioned
Rate of successful localization of the reflector
Time frame: 6 months
Percentage of reflectors successfull localized
Rate of successful recovery of the reflector
Time frame: 6 months
Percentage of reflectors successfull recovered
2 secondary outcomes
Rate of cases with negative margins
Time frame: 6 months
Rate of cases that have required a second excision
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Derived from this study: PubMed 41721162Gianmatteo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianmatteo Pagani, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Occult Breast Carcinoma, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianmatteo Pagani, MD (+390257489 ext. 308, gianmatteo.pagani@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful positioning of the reflector (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05963464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.