Intraoperative Ultrasound for Brain Tumor Surgery Enhanced by AI (NCT07376304) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Intraoperative Ultrasound for Brain Tumor Surgery Enhanced by AI
100 participantsStarted 2026-03
Plain-language summary
Intraoperative ultrasound is a versatile, low-cost imaging tool that has been shown to improve safety and efficacy in brain tumor surgery. However, its widespread adoption remains limited due to operator dependency, the complexity of image interpretation, the presence of artifacts, and a restricted field of view.
This project aims to prospectively evaluate, in a multicenter and non-randomized setting, a prototype real-time deep learning-based segmentation model for brain tumor delineation in intraoperative ultrasound. The model is designed to facilitate the identification of tumor tissue during surgery, potentially enhancing intraoperative decision-making and surgical precision.
By increasing the precision and accessibility of ioUS, this innovation is expected to enable safer and more complete resections, with the potential to improve both survival and quality of life for patients with brain tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Age ≥ 18 years.
* Scheduled for craniotomy and resection of a brain tumor with ioUS planned as part of the standard surgical workflow.
* Preoperative MRI available for surgical planning.
* Ability to obtain informed consent from the patient or legal representative.
Exclusion criteria:
• Inadequate ioUS image acquisition due to technical failure or intraoperative complications unrelated to the tumor.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an AI-enhanced ultrasound tool called BrainUS-AI to detect leftover tumor during brain surgery — how might having this tool used during my operation change what the surgeon is able to remove, compared to surgery without it?
2Since this is a Phase 3 trial, what does that mean for how much is already known about whether BrainUS-AI is safe and accurate, and are there any remaining uncertainties my surgical team would want me to understand before agreeing to participate?
3The trial isn't recruiting yet — if I'm facing surgery soon, should I proceed with standard surgical guidance now, or is it worth waiting to see if this trial opens and whether I might be eligible to discuss enrolling?
4How does the AI-ultrasound approach in this trial compare to other intraoperative imaging methods, like MRI during surgery, that might already be available at this hospital for detecting residual tumor?
5If the BrainUS-AI tool identifies what looks like remaining tumor during my surgery, how would the surgical team decide whether to act on that finding in real time, and could it affect the risks of the operation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic performance of BrainUS-AI for residual tumor detection at end of resection
Timeframe: During surgery (baseline, during resection, and end of resection), with the primary assessment at the end of resection on the final intraoperative ultrasound acquisition.