Single Step Lesion Annotation and Localization of Suspicious Breast Lesions

NCT05118295 | Terminated Early Phase 1 FDA Device

• 2 other identifiers: 2021-0842NCI-2021-11361
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Lesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SAVI Scout®

EXPERIMENTAL

marker is accurately placed in the breast tumor

Device: SAVI Scout®

Interventions

SAVI Scout® DEVICE

Savi Scout marker is placed within 1 cm of the breast tumor

SAVI Scout®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center website

Study Officials

• Tanya Moseley, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 11, 2021
• Study Start: April 11, 2022
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)