SCOUT® Radar Localization in Nonpalpable Breast Lesions

Status Recruiting

Clinical 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. 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05963464
Study type	Observational
Source	European Institute of Oncology
Contact	Gianmatteo Pagani, MD
Phone	+390257489
Email	gianmatteo.pagani@ieo.it
Status	Recruiting
Phase
Start date	February 1, 2023
Completion date	December 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

SCOUT® Radar Localization in Nonpalpable Breast Lesions — SAVISCOUT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms