Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SAVI Scout MD Localization |
Participants undergo image-guided placement of multiple Scout MD reflectors followed by breast-conserving surgery using the device for intraoperative localization. |
|
Recruiting Locations
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
More Details
- Status
- Recruiting
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute