This early phase I trial measures the effectiveness of a diagnostic device called the SAVI SCOUT Reflector to detect and mark the location of breast tumors in breast cancer patients where the cancer has not spread to other parts of the body. The SAVI SCOUT is a new surgical guidance system that does not use radiation or wires. To use SAVI SCOUT, the radiologist implants a small (size smaller than a grain of rice) device called the “SAVI SCOUT Reflector” inside breast tissue or lymph nodes under image-directed guidance before surgery. The SAVI SCOUT, which uses radar technology, guides the surgeon to precisely target the breast tissue during a lumpectomy or excisional biopsy procedure. The SAVI SCOUT Reflector may increase the accuracy of breast tumor removal and may result in fewer appointments needed for breast imaging.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05118295.
PRIMARY OBJECTIVE:
I. To provide pilot evidence that the SAVI SCOUT reflector can be successfully used to mark and subsequently localize breast tumors in patients with unifocal disease, with one single invasive procedure appointment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo SAVI SCOUT Reflector placement at the time of first mammography or ultrasound. After the SAVI SCOUT Reflector is placed, patients undergo a mammogram to record the placement and the location relative to the suspicious breast lesion.
ARM II: Patients undergo SAVI SCOUT Reflector placement at the time of imaging procedures while receiving chemotherapy. After the SAVI SCOUT Reflector is placed, patients undergo a mammogram to record the placement and the location relative to the suspicious breast lesion.
After completion of chemotherapy, all patients undergo ultrasound to check tumor response to chemotherapy and to check the position of the SAVI SCOUT Reflector in relation to the breast cancer. Patients proceed to standard of care surgery to remove the breast lesion and the SAVI SCOUT Reflector if it is placed in the breast beside the lesion or is placed near the breast lesion. Patients may undergo a second procedure to place another SAVI SCOUT Reflector if the original is placed far from the breast lesion.
Patients are followed up around 6-42 days after completion of surgery.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorTanya W. Moseley
