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NCT05118295 · ClinicalTrials.gov registry record · Early Phase 1
Single Step Lesion Annotation and Localization of Suspicious Breast Lesions
A Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 27
- Enrollment target
NCT05118295: Clinical Trial Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT05118295 is a Early Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 27 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05118295, a Early Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 27 participants
- Enrollment target
Study 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.
Interventions
- DEVICE SAVI Scout®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-04-11 |
| Est. Completion | 2025-01-22 |
| Phase | Early Phase 1 |
Why NCT05118295 stopped before completion
NCT05118295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 1 intervention - of which SAVI Scout® is the first listed.
NCT05118295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05118295 about?
NCT05118295 is a clinical study titled "Single Step Lesion Annotation and Localization of Suspicious Breast Lesions". 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 brea...
What is the current status of trial NCT05118295?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 27 participants. The study started on 2022-04-11. Estimated completion is 2025-01-22.
What interventions are being tested in trial NCT05118295?
The interventions under investigation include: SAVI Scout® (DEVICE).
Who is sponsoring clinical trial NCT05118295?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05118295's enrollment target sits among peer trials
27 963rd of 2000 higher than 1,024 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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