ClinicalTrials.gg
Not yet recruitingNCT07376304BrainUS-AIUpdated Sep 17, 2026

Intraoperative Ultrasound for Brain Tumor Surgery Enhanced by AI

A Phase 3 interventional study of BrainUS-AI real-time intraoperative ultrasound segmentation system in Brain Tumor Adult, sponsored by Hospital del Rio Hortega. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Hospital del Rio Hortega · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Brain Tumor Adult

Keywords

  • brain tumor
  • glioma
  • glioblastoma
  • low-grade glioma
  • high-grade glioma
  • ious
  • computer vision
  • AI
  • ultrasound
03

In context

Brain Neoplasms

2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Hospital del Rio Hortega is the lead sponsor of 27 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 from the patient or legal representative.

Exclusion criteria

Exclusion criteria:

  • Inadequate ioUS image acquisition due to technical failure or intraoperative complications unrelated to the tumor.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Real-time AI-assisted intraoperative ultrasound segmentation

    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.

    Device: BrainUS-AI real-time intraoperative ultrasound segmentation system

Interventions

  • DeviceBrainUS-AI real-time intraoperative ultrasound segmentation system

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During surgery (baseline, during resection, and end of resection), with the primary assessment at the end of resection on the final intraoperative ultrasound acquisition.

07

Study locations

No study locations are listed for this record.

08

References and documents

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 39858097 ↗
  • Cepeda 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

Of 56 phase 3 interventional studies under Brain Neoplasms, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 269. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2026
First posted
Jan 29, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2027
CompletionEst.
Jun 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07376304
Lead sponsor
Hospital del Rio Hortega
Collaborators
University Hospital Bratislava
Responsible party
Santiago Cepeda (Staff Neurosurgeon, Hospital del Rio Hortega) — Principal investigator
First posted
Jan 29, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Santiago Cepeda, MD., Ph.D.
Contact
scepedac@saludcastillayleon.es
+34651035158

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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