Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963464
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-07-19
Brief Title:
RADIOSO MILAN I RADar Reflector localisatiOn-SCOUT for carcinOma Mammae the MILAN IEO Experience I
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
RADIOSO MILAN I RADar Reflector localisatiOn-SCOUT for carcinOma Mammae the MILAN IEO Experience I
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADIOSO
Brief 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
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 318 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 13 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 daythe 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
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 daythe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None