SAVI Scout MD for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the SAVI Scout MD system, a new tool that helps surgeons locate and remove breast cancer more precisely during surgery. The device uses tiny radar reflectors instead of wires, which can be placed days or weeks before surgery, potentially reducing the need for a second operation. It is ideal for women with a breast tumor visible via ultrasound, mammogram, or MRI who require surgery. Participants must be able to undergo their surgery at Moffitt Cancer Center. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in breast cancer surgery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the SAVI Scout MD system is safe for use in breast cancer surgery?
Research has shown that the SAVI Scout system and its advanced version, the SAVI Scout MD, are safe for use. The FDA approved the original SCOUT technology in 2014, and in 2017, it received approval for long-term use without time limits. This indicates thorough testing and a consistent safety record for patients over the years.
The system employs radar reflectors, avoiding radiation and wires, which makes it safer than some other methods. Studies have demonstrated that the SAVI Scout MD is as safe as the original system, suggesting it will be well-tolerated by patients.12345Why are researchers excited about this trial?
Unlike the standard methods for breast cancer surgery that often rely on wire localization, the SAVI Scout MD system is unique because it uses non-radioactive, radar-based reflectors for tumor localization. This innovative system allows for more precise and flexible placement, which can improve surgical outcomes and patient comfort. Researchers are excited about this treatment because it offers a less invasive and more accurate approach, potentially leading to better conservation of healthy breast tissue and reduced reoperation rates.
What evidence suggests that the SAVI Scout MD system is effective for breast cancer surgery?
Research has shown that the SAVI Scout MD system, used in this trial, is highly effective for breast cancer surgeries. Studies have found a success rate of over 99% for placing and retrieving the marker used in this system. This technology enables surgeons to locate and remove tumors with greater accuracy, reducing the need for additional surgeries. In the cases studied, targeted breast areas and markers were successfully removed every time. The system enhances surgical precision and outcomes, increasing the success of breast cancer surgeries.14567
Who Is on the Research Team?
Marie Lee, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for people diagnosed with localized breast cancer who are scheduled for surgery to remove the tumor. Specific inclusion and exclusion criteria are not listed, but participants should be eligible for breast surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Preparation
Placement of multiple Scout MD reflectors for intraoperative localization
Surgery
Breast-conserving surgery using the SAVI Scout MD system for tumor localization
Follow-up
Participants are monitored for successful operation rate and surgical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- SAVI Scout MD system
Trial Overview
The study is testing the SAVI Scout MD system, which uses small radar reflectors (instead of wires) placed in or near the tumor before surgery to help surgeons find and remove it more accurately.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants undergo image-guided placement of multiple Scout MD reflectors followed by breast-conserving surgery using the device for intraoperative localization.
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Merit Medical
Collaborator
Citations
Case Report: SCOUT MD™ four reflector technology ... - PMC
Successful DCIS resection was confirmed by post-resection tomosynthesis imaging of the partial mastectomy specimen, and negative margins were achieved. The ...
Evaluation and Outcomes of SAVI Scout MD for Localized ...
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 ...
SAVI SCOUT® Radar Localization for Lumpectomy
SAVI SCOUT® makes lumpectomies for early-stage breast cancer easier by pinpointing tumors for more precise removal and more successful outcomes.
SCOUT® Radar Localization | Tumor Localization
SCOUT is proven to improve radiology workflow and significantly reduce OR delays. Using SCOUT, surgeons can precisely target the affected tissue
5.
oncology-central.com
oncology-central.com/new-surgical-guidance-system-safe-and-effective-for-localizing-breast-tumors/New surgical guidance system safe and effective for ...
In all cases, targeted lesions and reflectors were successfully removed, and the primary results suggest a 100% success rate of SAVI SCOUT.
SAVI Scout for Breast Lesions · Info for Participants
Research has shown that the SAVI Scout system, approved by the FDA since 2014, is safe. In 2017, the FDA approved it for long-term use without time limits,
SAVI SCOUT
system uses no radiation and no wires. Quality and Safety Data for Memorial Healthcare System
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