Intraoperative Ultrasound for Brain Tumor Surgery Enhanced by AI

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital del Rio Hortega

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • BrainUS-AI real-time intraoperative ultrasound segmentation system

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Hospital del Rio Hortega

Lead sponsor

University Hospital Bratislava

Collaborator