Long Term Use of SAVI SCOUT: Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Longer Duration Use of the SAVI SCOUT Surgical Guidance System for Excision of Breast and Axillary Lesions in Neo-adjuvant Therapy Patients: A Pilot Study

Conditions
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Breast Diseases

Intervention / Treatment
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* Device: SAVI SCOUT Surgical Guidance System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCOUT device<br>The study population consists of 25 - 35 adult surgical patient volunteers who plan to have definitive breast cancer surgery at Memorial Healthcare System (MHS) Hospitals after neoadjuvant treatment. The investigator will identify subjects who meet inclusion/exclusion criteria, obtain patient's consent and schedule the subject for the SAVI SCOUT Surgical Guidance System procedure. All study participants will receive the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Neoadjuvant treatment decisions will be determined by patient's medical oncologist. | Device: SAVI SCOUT Surgical Guidance System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 31 - 365 days prior to surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neoadjuvant treatment, surgical guidance system