Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery

Phase 2RecruitingNCT07686250

H. Lee Moffitt Cancer Center and Research Institute37 enrolled

Overview

The purpose of the study is to evaluate how precise the SAVI Scout MD is and how easy it is for surgeons to use during surgery. The SAVI Scout MD system uses tiny radar reflectors instead of wires, can be placed days or weeks before surgery, helps surgeons find the cancer more precisely and may lower the chance of needing a second surgery.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

SAVI Scout MD systemDEVICE

Implantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult females who are 18 years of age or older at time of signing informed consent will be eligible. * Must have ability to comprehend and the willingness to sign written informed consent for study participation. * Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target. Exclusion Criteria: * Patients undergoing mastectomy for resection of the targeted lesion. * Planned excision of multiple separate sites in the ipsilateral breast. * Inability to undergo surgery at Moffitt Cancer Center.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Successful Operation Rate (SOR)

Proportion of patients achieving complete tumor resection with negative surgical margins ("no tumor on ink" or ≥2 mm for DCIS).

Time frame: Up to 6 weeks.

Central Contacts

Diane Tendoh

CONTACT

813-745-4979 Diane.Tendoh@moffitt.org

Data from ClinicalTrials.gov

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