See if SAVI Scout MD helps surgeons localize breast cancer more precisely
Official title: Clinical Evaluation and Outcomes of Multi-signal SAVI Scout (Scout MD) Localized Breast Conserving Surgery
Run by H. Lee Moffitt Cancer Center and Research Institute · NCT07686250 · Data updated 2026-11-12
This study tests whether the SAVI Scout MD radar reflectors help surgeons find and remove breast cancer more accurately, potentially reducing the need for a second operation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 37 (estimated) |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Status | Recruiting |
| Started | July 29, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07686250 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women 18 years or older with a biopsy-confirmed in-breast malignancy suitable for breast-conserving surgery and who are planning to have multiple localizing markers placed at Moffitt Cancer Center.
✕Probably not a fit
Patients who undergo mastectomy or planned excision of multiple separate sites, or cannot have surgery at Moffitt, may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial seeks to determine the precision and ease of use of the SAVI Scout MD system for localizing breast tumors before surgery. The system uses radar reflectors placed before surgery to guide the surgeon during the operation, potentially allowing for targeted tumor removal and fewer reoperations. Adult female participants with identifiable in-breast malignancies undergoing surgical resection with localized markers are enrolled at Moffitt Cancer Center, with Merit Medical as a collaborator. The study focuses on safety and technical performance, including how well the markers aid intraoperative localization. Participation requires informed consent and the ability to undergo planned breast-conserving surgery at the host center.
Why it matters
Potential benefit: If successful, the approach could improve surgical precision and reduce the need for additional surgeries.
How similar studies have gone: Previous localization technologies have shown promise in improving surgical guidance, but this specific SAVI Scout MD approach in this setting is being evaluated for added precision and practicality.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Moffitt Cancer Center
Tampa, Florida, United States Recruiting
Study contacts
- Principal investigator: Marie Lee, MD — Moffitt Cancer Center
- Study coordinator: Diane Tendoh
- Email: Diane.Tendoh@moffitt.org
- Phone: 813-745-4979
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.