Single Step Lesion Annotation and Localization of Suspicious Breast Lesions

Study Overview
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Brief Summary
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The SAVI Reflector is a nonradioactive infrared (IR)-activated electromagnetic wave device that can be implanted in the breast or lymph nodes under image-directed guidance, typically by mammography or sonography. Intraoperatively, the SCOUT hand-held device is then percutaneously applied to the breast or lymph node, creating an audible signal on the device console with a gradient which correlates to distance (in mm) from the target lesion and marker. The Savi Scout surgical guidance system was approved by the U.S. Food and Drug Administration in 2014. Furthermore, it was approved for long term use, with no restrictions on the length of time in 2017. The system consists of an implantable reflector with a 4-mm body size, preloaded in a 16-gauge deliverable needle, a hand-held probe and a console. The reflector consists of an IR light receptor, resistor switch and two antennae. This is placed into or near the target through a 16G needle under mammographic or sonographic guidance. The hand-held probe detects pulses of infrared (IR) light and radar wave signals, received by the console system, which then emits and receives signals back to the reflector to provide real time localization and target proximity information to the surgeon. The SCOUT console provides audible and visual feedback intraoperatively, the frequency of which increases as the handheld reader approaches the implanted reflector. After excision of the breast lesion, the handheld reader can be used to immediately confirm removal of the reflector, present in the lumpectomy specimen, and subsequent quiescence of radar signal in the breast.

Detailed Description
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Primary Endpoint: -To measure success of surgical retrieval of SAVI Scout placed at the time of initial, or mid-chemo, imaging studies. To demonstrate the successful excision of unifocal tumor tissue and/or tumor bed (after neoadjuvant chemotherapy). Other Endpoints: Safety: Number of device-related adverse events. Radiological Placement Radiologist-rated ease of placement using Likert scale Accuracy of placement: Accurate: Within the breast tumor Marginal: Within the peritumoral tissue < or equal 5 mm Inadequate: More than 5 mm Unacceptable: Required additional localization device placement Success rate of maintained position of SAVI Scout, measured on interval imaging: Accurate: Within the breast tumor Marginal: Within the peritumoral tissue < or equal 5 mm Inadequate: More than 5 mm

Official Title
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Single Step Lesion Annotation and Localization of Suspicious Breast Lesions

Conditions
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Breast Lesions

Intervention / Treatment
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* Device: SAVI Scout®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patients >18 years of age at the time of consent. Unifocal BIRADS-5 or -6 lesions at the time of diagnostic imaging Unifocal, histologically-proven T0-T3, N0-1 invasive breast cancer at the time of mid-chemotherapy imaging if receiving neoadjuvant therapy Exclusion criteria Distant metastasis Inflammatory breast carcinoma Nickel allergy Patients with active cardiac implants Patients participating in Protocol 2016-0046, Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders to Neoadjuvant Therapy Patients participating in Protocol AFT-25, Comparison of Operative to Monitoring and Endocrine Therapy for Low-risk DCIS (COMET) Pregnant women will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAVI Scout®<br>marker is accurately placed in the breast tumor | Device: SAVI Scout®<br>* Savi Scout marker is placed within 1 cm of the breast tumor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks |  | through study completion, an average of 1 year |