SCOUT® Radar Localization in Nonpalpable Breast Lesions (SAVISCOUT)

SCOUT® Radar Localization: Experience With 300 Patients at the European Institute of Oncology

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Occult Breast Carcinoma
• Intervention / Treatment: Device: SCOUT® Radar occult breast lesion Localization

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Gianmatteo Pagani, MD; Phone Number: 308 +390257489; Email: gianmatteo.pagani@ieo.it
• Study Contact Backup: Name: Claudia Sangalli, MSc; Phone Number: 840 +390257489; Email: claudia.sangalli@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Pagani Gianmatteo, MD; Email: gianmatteo.pagani@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of nonpalpable breast lesion or lymph nodes requiring conservative surgical excision.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful positioning of the reflector	Percentage of reflectors successfull positioned	1 week
Rate of successful localization of the reflector	Percentage of reflectors successfull localized	6 months
Rate of successful recovery of the reflector	Percentage of reflectors successfull recovered	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of cases with negative margins	percentage of cases with negative margins	6 months
Rate of cases that have required a second excision	Percentage of cases that have required a second excision	6 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Gianmatteo Pagani, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IEO 1911/

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No