Long Term Use of SAVI SCOUT: Pilot Study
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the performance of FDA-cleared SAVI SCOUT Breast
      Localization and Surgical Guidance System (SCOUT) over a longer duration prior to surgery.
      The device is a non-wire system, which uses nonradioactive light-activated radar, to provide
      breast surgeons with real-time guidance to locate and remove the target lesion in the breast
      and/or axillary tissue. The SCOUT device standard of care use is placement up to 30 days
      prior to surgery to assist surgeons in the localization and retrieval of breast/axillary
      lesions. Routine image-guided methods (Mammography, Ultrasound, and CT) are used. In this
      study, investigators will assess the longer term placement of the SCOUT device over an
      extended time (31 - 365 days) in order to address the needs of patients who require
      neoadjuvant treatment prior to definitive surgery.
    

Detailed description: 
      The SAVI SCOUT (Cianna Medical, Inc.) surgical guidance system received 510(k) U.S. Food and
      Drug Administration (FDA) approval in August 2014. This system is used as a standard of care
      since 2015 in the Memorial Healthcare System (MHS) operating rooms by experienced breast
      surgeons (over 150 MHS breast cancer patients and over 5,000 U.S. breast cancer patients as
      of September 2016). In MHS standard of care practice, the device is placed at the target
      lesion(s) under image-guidance by the radiologist up to 30 days prior to surgery.

      Patients with certain types of breast cancer undergo neoadjuvant treatment with biologic
      (hormonal) and/or chemotherapy with the goal of decreasing the tumor volume prior to
      definitive surgery. If the original cancer lesion(s) resolve completely, this is called
      complete pathologic response (pCR). pCR and even a partial response, while good for the
      patient, can result in disappearance or poor visualization of the target and often render
      pre-operative image-guided localization by the radiologist more difficult and less reliable.
      This can result in unintended larger, more disfiguring breast cancer surgery. Therefore, if
      the SCOUT device can be placed prior to treatment response, when the lesion is clearly
      visualized on imaging, accurate image-guided targeting is optimal and thus placement and
      subsequent surgery should be more accurate. If this pilot study demonstrates successful
      performance of the device without device-related complications, it will bring improved value
      to future patients who will require fewer and/or less extensive pre-operative and surgical
      procedures. Some value may also be provided to subjects as the targeting before tumor
      shrinkage is expected to be more accurate.

      Thus, this pilot study will assess the performance of FDA-cleared SCOUT system over a longer
      duration prior to breast and/or axillary lymph node surgery.
    

Intervention name(s): SAVI SCOUT Surgical Guidance System
Intervention type(s): Device
Intervention description(s): SAVI SCOUT Surgical Guidance System is a non-wire system, which uses nonradioactive light-activated radar, to provide breast surgeons with real-time guidance to locate and remove the target lesion in the breast and/or axillary tissue.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: breast cancer; neoadjuvant treatment; surgical guidance system