Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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.

SAVI SCOUT Surgical Guidance System

Mary Hayes-Macaluso, MD

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.

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.

Long Term Use of SAVI SCOUT: Pilot Study

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

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.

Cianna Medical, Inc.

Envision Healthcare Scientific Intelligence, Inc.

Adverse events from underlying diseases and related to neoadjuvant treatments were not intended to be collected. The written Protocol was amended to clarify this point. All reported SAEs were unrelated to the investigational device and collected prior to the Protocol amendment. The collected events were all previously known as anticipated side effects of chemotherapy and fertility preservation.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Long Term Use of SAVI SCOUT: Pilot Study	NCT03015649	Breast Diseases	SAVI SCOUT Surg...	18 Years - 90 Years	Envision Healthcare Scientific Intelligence, Inc.
Long Term Use of SAVI SCOUT: Pilot Study	NCT03015649	Breast Diseases	SAVI SCOUT Surg...	18 Years - 90 Years	Envision Healthcare Scientific Intelligence, Inc.

Spots Global Cancer Trial Database for surgical guidance system