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Trial Title:
RADIOSO MILAN I (RADar Reflector localisatiOn-SCOUT for carcinOma Mammae, the MILAN IEO Experience I)
NCT ID:
NCT05963464
Condition:
Breast Cancer
Occult Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
SCOUT® Radar occult breast lesion Localization
Description:
The SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive
micro-impulses to guide surgical excision in real time.
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.
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:
1. Long-term positioning of the reflector, as in the case of patients undergoing
neoadjuvant treatment
2. Reflector placement in malignant lymphadenopathy prior to neoadjuvant chemotherapy
3. Placement of multiple reflectors, or use of both SRL and ROLL in patients with
multifocal or multicentric neoplasia referred for conservative surgery
4. 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
5. Placement of the reflector using MR-compatible introducer needles
Criteria for eligibility:
Study pop:
Patients with diagnosis of nonpalpable breast lesion or lymph nodes requiring
conservative surgical excision.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Pagani Gianmatteo, MD
Email:
gianmatteo.pagani@ieo.it
Start date:
February 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963464
