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临床试验/NCT07376304
NCT07376304尚未招募3 期

Optimization of Intraoperative Ultrasound Use in Brain Tumor Surgery Through Artificial Intelligence-Based Techniques

Hospital del Rio Hortega0 个研究点目标入组 100 人开始时间: 2026年12月1日最近更新:
干预措施

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
主要终点
Diagnostic performance of BrainUS-AI for residual tumor detection at end of resection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Inadequate ioUS image acquisition due to technical failure or intraoperative complications unrelated to the tumor.

研究组 & 干预措施

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.

干预措施: BrainUS-AI real-time intraoperative ultrasound segmentation system (Device)

结局指标

主要结局

Diagnostic performance of BrainUS-AI for residual tumor detection at end of resection

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

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.

次要结局

未报告次要终点

研究者

发起方
Hospital del Rio Hortega
申办方类型
Other
责任方
Principal Investigator
主要研究者

Santiago Cepeda

Staff Neurosurgeon

Hospital del Rio Hortega

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