Breast Diseases
Conditions
Keywords
breast cancer, neoadjuvant treatment, surgical guidance system
Brief 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.
Interventions
DEVICESAVI SCOUT Surgical Guidance System
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.
Sponsors
Cianna Medical, Inc.
Envision Healthcare Scientific Intelligence, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient is willing and able to provide informed consent. Patient SCOUT device(s) is placed as part of routine care or study but before neoadjuvant treatment begins. * Patient is female. * Patient is between the ages of 18 and 90 years. * Patient has breast cancer and will undergo neoadjuvant therapy and excision at Memorial Healthcare System. * Patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study (1 - 13 months). * Patient reads or understands English or Spanish.
Exclusion criteria
* Patient is pregnant. * Patient has pacemaker or implantable defibrillators (These have not been bench tested as of September 2016). * Patient has known or suspected nickel allergy. * Patient is scheduled or receiving investigational drugs for neoadjuvant regimen. (This could confound UADE of this device.) * Patient has any condition that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. * Patient has other malignancy except for adequately treated and cured basal or squamous cancer, curatively treated in situ disease or any other cancer for which the patient has been disease free for greater than or equal to 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Considered to Have a Successful Surgery | 31 - 365 days prior to surgery | The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SCOUT Device All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | SCOUT Device |
|---|---|
| Age, Continuous | 50 years |
| Node Positive | 23 Participants |
| Race/Ethnicity, Customized African American | 12 Participants |
| Race/Ethnicity, Customized Caucasian | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 11 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Number of Participants Considered to Have a Successful Surgery
The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery.
Time frame: 31 - 365 days prior to surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SCOUT Device | Number of Participants Considered to Have a Successful Surgery | 34 Participants |