Brain Tumor AdultPhase 3BrainUS-AINCT07376304
Intraoperative Ultrasound for Brain Tumor Surgery Enhanced by AI
A Phase 3 study testing BrainUS-AI real-time intraoperative ultrasound segmentation system in people with Brain Tumor Adult, run by Hospital del Rio Hortega.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor Adult
- What is being tested?
- BrainUS-AI real-time intraoperative ultrasound segmentation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inadequate ioUS image acquisition due to technical failure or intraoperative complications unrelated to the tumor.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimization of Intraoperative Ultrasound Use in Brain Tumor Surgery Through Artificial Intelligence-Based Techniques
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.
Read the detailed description
Brain tumor surgery presents major challenges due to the complex anatomy of the brain and the infiltrative nature of these lesions, which are often located near eloquent areas. One of the key determinants of patient survival is the extent of tumor resection, provided it can be achieved without compromising neurological function 1. To maximize safe resection, neurosurgeons rely on a variety of intraoperative adjuncts, including fluorescent agents, neuronavigation, direct electrical stimulation, and advanced intraoperative imaging techniques, most notably intraoperative magnetic resonance imaging (ioMRI) and intraoperative ultrasound (ioUS) 2.
Although ioMRI offers excellent resolution and accuracy, its high cost, logistical demands, and complexity of integration limit its availability to a small number of specialized centers 3. In contrast, ioUS is a low-cost, versatile modality that integrates naturally into the surgical workflow 4-6. Nevertheless, its broader adoption has been limited by several factors: high operator dependency, a steep learning curve, and interpretation challenges related to artifacts, non-standard imaging planes, low contrast between tumor and normal brain, and a restricted field of view.
Over the past decades, research on AI-based segmentation of brain tumors has advanced substantially, but most work has focused on MRI 7. In the context of ioUS, early studies such as Ritschel et al. 8 demonstrated that supervised classification models (e.g., support vector machines) could distinguish tumor from healthy tissue in contrast-enhanced ultrasound, but these approaches were labor-intensive and limited to small datasets. Ilunga-Mbuyamba et al. 9 later investigated multimodal registration between ioUS and MRI to enhance segmentation, but clinical feasibility was constrained by the need for accurate co-registration. More recently, deep learning-based approaches by Canalini et al. 10 and Carton et al. 11 have been applied to segment surgical cavities and tumor volumes in ioUS images.
State-of-the-art methods such as those reported by Faanes et al. 12, using nnU-Net architectures, have achieved promising Dice similarity coefficients of 0.6-0.9 on public datasets such as RESECT-SEG 13 and ReMIND 14. However, these models were not designed for real-time inference and have not undergone validation in live surgical settings. Other approaches, such as that of Dorent et al. 15, have relied on synthetic ultrasound images derived from preoperative MRI, raising concerns about generalizability to real ioUS data. Overall, despite these advances, clinical translation remains limited due to the unique challenges of ioUS, including lower spatial resolution, image heterogeneity, and variability in acquisition protocols.
In other medical domains, AI-assisted ultrasound segmentation has demonstrated real-time feasibility. For example, Hu et al. 16 implemented U-Net-based models for breast lesion segmentation at 16 frames per second (FPS) with Dice scores exceeding 0.75, while Wei et al. 17 applied YOLO-based detection to identify carotid plaques with 98.5% accuracy at 39 FPS. Despite their efficiency and accuracy, similar approaches have yet to be implemented and clinically validated for brain tumor surgery using ioUS.
Our project aims to address this gap by conducting a multicenter, prospective, non-randomized validation of a prototype deep learning-based segmentation model specifically designed for real-time intraoperative brain tumor ultrasound. The model operates at surgical frame rates, automatically delineating tumor boundaries directly on the live ultrasound feed, with the goal of assisting intraoperative decision-making, maximizing the extent of resection when oncologically appropriate, and preserving neurological function.
This study builds upon our prior work, which has established a strong scientific foundation for the proposed validation. In our recent publication, "Deep Learning-Based Glioma Segmentation of 2D Intraoperative Ultrasound Images: A Multicenter Study Using the Brain Tumor Intraoperative Ultrasound Database (BraTioUS)" 18, we trained and validated a deep learning model for brain tumor segmentation using multicenter data from BraTioUS-DB-marking a milestone in ioUS research. In a second study, "Real-Time Brain Tumor Detection in Intraoperative Ultrasound: From Model Training to Deployment in the Operating Room"19, we developed and prospectively evaluated a real-time computer vision detection model in the operating room. Together, these contributions provide a robust framework for advancing real-time AI-based segmentation in intraoperative ultrasound, directly aligned with the objectives of the present study.
- Conditions
- Brain Tumor Adult
- Being tested
- BrainUS-AI real-time intraoperative ultrasound segmentation system
- Keywords
- brain tumor, glioma, glioblastoma, low-grade glioma, high-grade glioma, ious, computer vision, AI, ultrasound
- Medical subject headings
- Brain Neoplasms, Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainUS-AI real-time intraoperative ultrasound segmentation systemDevice
A prototype AI-based device (software system) that performs real-time deep learning segmentation of brain tumor tissue on intraoperative ultrasound (ioUS) and displays the segmentation as an overlay on the live ultrasound feed during surgery. The system is used as an adjunct to standard-of-care ioUS without mandating any change to the planned surgical strategy; intraoperative decisions remain under the surgeon's responsibility. System logs capture processing performance (e.g., FPS, end-to-end latency, operational uptime) and outputs used for subsequent technical validation and workflow/usability assessments.
| Study group | Role | What they receive |
|---|---|---|
| Real-time AI-assisted intraoperative ultrasound segmentation | Experimental | Participants undergoing standard-of-care brain tumor resection with intraoperative ultrasound (ioUS) will use a prototype real-time deep learning-based segmentation system that overlays automated tumor delineation on the live ultrasound feed during surgery. The tool is used as an adjunct to routine intraoperative imaging and does not mandate changes to the surgical strategy; the surgeon remains fully responsible for intraoperative decision-making. Technical performance (e.g., segmentation accuracy, latency/FPS, operational stability), feasibility/workflow impact, residual tumor detection agreement, and surgeon-reported usability will be prospectively collected across participating centers. Receives: Device: BrainUS-AI real-time intraoperative ultrasound segmentation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of BrainUS-AI for residual tumor detection at end of resection
Residual tumor presence/absence will be determined by the BrainUS-AI segmentation overlay during the final intraoperative ultrasound acquisition (when the surgeon considers the resection complete). This binary classification (residual present/absent) will be compared against early postoperative MRI when available (reference standard), and agreement with the surgeon's intraoperative assessment will also be recorded. Diagnostic performance will be reported as sensitivity, specificity, PPV, and NPV with 95% confidence intervals, and concordance will be assessed using Cohen's kappa.
Measured: During surgery (baseline, during resection, and end of resection), with the primary assessment at the end of resection on the final intraoperative ultrasound acquisition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bratislava
- Responsible party
- Principal investigator, Santiago Cepeda, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376304
- Sponsor's protocol ID
- PI-25-191-H
- Acronym
- BrainUS-AI
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cepeda S, Esteban-Sinovas O, Singh V, Shetty P, Moiyadi A, Dixon L, Weld A, Anichini G, Giannarou S, Camp S, Zemmoura I, Giammalva GR, Del Bene M, Barbotti A, DiMeco F, West TR, Nahed BV, Romero R, Arrese I, Hornero R, Sarabia R. Deep Learning-Based Glioma Segmentation of 2D Intraoperative Ultrasound Images: A Multicenter Study Using the Brain Tumor Intraoperative Ultrasound Database (BraTioUS). Cancers (Basel). 2025 Jan 19;17(2):315. doi: 10.3390/cancers17020315.
PubMed 39858097Cepeda S, Esteban-Sinovas O, Romero R, Singh V, Shett P, Moiyadi A, Zemmoura I, Giammalva GR, Del Bene M, Barbotti A, DiMeco F, West TR, Nahed BV, Arrese I, Hornero R, Sarabia R. Real-time brain tumor detection in intraoperative ultrasound: From model training to deployment in the operating room. Comput Biol Med. 2025 Jul;193:110481. doi: 10.1016/j.compbiomed.2025.110481. Epub 2025 May 30.
PubMed 40449046