Breast Cancer
Conditions
Brief summary
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.
Interventions
DEVICESAVI Scout MD system
Implantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Merit Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Operation Rate (SOR) | Up to 6 weeks. | Proportion of patients achieving complete tumor resection with negative surgical margins ("no tumor on ink" or ≥2 mm for DCIS). |
Countries
United States
Contacts
CONTACTDiane Tendoh
PRINCIPAL_INVESTIGATORMarie Lee, MD
Moffitt Cancer Center
Outcome results
None listed