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

NCT05963464 | Recruiting

• 1 other identifier: IEO 1911/
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Occult Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Rate of cases with negative margins

  6 months

• Rate of cases that have required a second excision

  6 months

Interventions

SCOUT® Radar occult breast lesion Localization DEVICE

The SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive micro-impulses to guide surgical excision in real time.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gianmatteo Pagani, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianmatteo Pagani, MD

CONTACT

+390257489; gianmatteo.pagani@ieo.it

Claudia Sangalli, MSc

CONTACT

+390257489; claudia.sangalli@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)