NCT05118295

Single Step Lesion Annotation and Localization of Suspicious Breast Lesions

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Breast Lesions

Interventions

Type	Name	Description
DEVICE	SAVI Scout®	Savi Scout marker is placed within 1 cm of the breast tumor

Timeline

• Start date: 2022-04-11
• Primary completion: 2025-01-22
• Completion: 2025-01-22
• First posted: 2021-11-11
• Last updated: 2025-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study