Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery
Clinical Evaluation and Outcomes of Multi-signal SAVI Scout (Scout MD) Localized Breast Conserving Surgery
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well SAVI Scout MD helps surgeons find breast cancer and how easy it is to use. It uses tiny radar markers instead of wires and may lower the chance of needing another surgery. The study is for adult women having breast cancer surgery that needs more than one marker.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older when they sign the study consent form.
- Able to understand the study and willing to sign a form agreeing to take part.
- Have at least one breast cancer area seen on ultrasound, a mammogram (breast X-ray), or MRI scan. A clip left after a biopsy may also help mark the target if seen on ultrasound or a mammogram.
- Agree to surgery at Moffitt Cancer Center to remove the cancer using more than one marker to guide the surgeon.
Who can't join
- Having a mastectomy (surgery to remove the breast) to remove the cancer area being studied.
- Planning to have several separate areas removed from the same breast.
- Unable to have surgery at Moffitt Cancer Center.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
FL
- Moffitt Cancer Center · Tampa, FL 33612Marie Lee, MD · Principal investigatorBrian Czerniecki, MD · Sub-investigatorDavid Detz, MD · Sub-investigatorNazanin Khakpour, MD · Sub-investigatorMore trials in Tampa