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Automated Radiation Target Contouring and Treatment Planning Via RATA: A Multi-Center RCT

2026年11月2日 更新者:zhaoxiaohui

Automated Target Volume Contouring and Intelligent Treatment Planning Based on a Multi-Agent Collaborative Radiotherapy Large Model (RATA): A Multi-Center Validation and Prospective Randomized Controlled Trial

Radiotherapy, a cornerstone of comprehensive cancer treatment, relies heavily on clinician expertise for target volume contouring and treatment planning. Consequently, clinical practice is often constrained by procedural bottlenecks, inter-observer variability, and prolonged iterative feedback cycles. Although current artificial intelligence (AI) models have demonstrated progress in automated contouring, key limitations persist, including insufficient integration of multimodal clinical text, a lack of closed-loop dosimetric feedback, and limited generalizability across complex cancer types.

This study aims to develop and validate RATA (Radiotherapy Treatment Multi-Agent Assistant), a novel large model system powered by a collaborative multi-agent architecture. Driven by Large Language Model (LLM) decision engines, RATA processes pathological imaging, electronic health records (EHR), and multimodal medical data to construct a end-to-end, fully automated closed-loop pipeline encompassing "target contouring, plan design, dosimetric evaluation, and reflective refinement." Innovatively breaking through traditional unidirectional radiotherapy workflows, the system establishes a dosimetric feedback-driven adaptive iteration mechanism, leveraging dose distribution outcomes to guide multi-agent dynamic fine-tuning of target volumes, thereby mimicking the collaborative clinical logic between senior radiation oncologists and medical physicists.

For validation, this study adopts a multi-center, three-stage clinical validation framework-comprising multi-center retrospective validation, human-AI collaborative efficacy assessment, and a prospective randomized controlled trial (RCT)-to comprehensively evaluate the system's performance in improving contouring precision, mitigating experience-dependent disparities across clinician seniority, and reducing total workflow processing time. Implementation of the RATA platform holds potential to eliminate redundant operational steps, enabling a minute-level "scan-to-treat" response. Furthermore, its natural language interaction interface optimizes human-AI collaboration and substantially reduces clinical workload. Overall, this study not only establishes a standardized, intelligent assistance paradigm for precision radiation oncology but also provides essential evidence-based support and technological foundations for the clinical translation of multimodal AI in complex cancer management.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

62

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Guangdong
      • Guangzhou、Guangdong、中国、510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • 接触:
        • 首席研究员:
          • Xiaohui Zhao, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Pathologically confirmed malignant neoplasm requiring definitive or adjuvant radiotherapy.
  • Availability of verified pathology report.
  • Availability of baseline imaging examinations and diagnostic reports.
  • Availability of standardized and complete clinical electronic health records.

Exclusion Criteria:

  • Incomplete clinical, imaging, or follow-up data.
  • Presence of multiple primary malignancies.
  • Patients scheduled for salvage or palliative radiotherapy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:RATA-Assisted Workflow Arm

Patients in this arm receive radiotherapy using the RATA-assisted "scan-to-treat" model. Patients remain in position on the couch while the Multi-Agent Collaborative Radiotherapy Large Model (RATA) executes target volume contouring, treatment planning, dosimetric evaluation, and reflective refinement in a closed-loop automated workflow, enabling rapid delivery of the first fraction.

An AI-driven multi-agent platform utilizing large language model decision engines to automatically perform target volume contouring, dosimetric plan generation, evaluation, and adaptive refinement for cancer radiotherapy.

有源比较器:Standard Offline Workflow Arm

Patients in this arm follow the traditional offline clinical workflow. After initial simulation CT scanning, patients leave the treatment room while radiation oncologists and medical physicists manually perform target contouring and treatment planning according to standard practice. Patients return to the clinic at a later scheduled time for their first radiation fraction.

Conventional offline radiation therapy planning workflow, where target volume contouring and treatment planning are manually performed by radiation oncologists and medical physicists according to routine institutional protocols.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Total Closed-Loop Workflow Duration
大体时间:At the time of simulation and treatment planning for each participant (up to 1 day)

Total time (in minutes) required for the complete end-to-end radiotherapy planning closed-loop workflow, measured from initial CT simulation scan completion to final clinical treatment plan approval and readiness for first fraction delivery.

At the time of simulation and treatment planning for each participant (up to 1 day)

次要结果测量

结果测量
措施说明
大体时间
Clinical Acceptance Rate of Treatment Plans
大体时间:At plan evaluation prior to treatment delivery (up to 1 day)

Percentage of treatment plans rated as clinically acceptable (score ≥3 on a 5-point Likert scale) by senior radiation oncologists without substantial manual re-planning.

At plan evaluation prior to treatment delivery (up to 1 day)
Planning Time and Workload Reduction Rate
大体时间:At plan evaluation prior to treatment delivery (up to 1 day)

Total clinician active manual intervention time (contour editing and plan optimization duration in minutes) and percentage of labor time saved compared to the standard manual workflow.

At plan evaluation prior to treatment delivery (up to 1 day)
Contouring Accuracy Metrics and Dosimetric Parameters
大体时间:At plan evaluation prior to treatment delivery (up to 1 day)

Geometric similarity metrics including Dice Similarity Coefficient (DSC), 95% Hausdorff Distance (HD95), and Average Surface Distance (ASD); dosimetric indicators including Target Coverage (V95%), Conformity Index (CI), Homogeneity Index (HI), and Organs-at-Risk (OAR) dose constraints.

At plan evaluation prior to treatment delivery (up to 1 day)
First Setup Verification Pass Rate
大体时间:At the first fraction of radiotherapy delivery (Day 1 of treatment)

Proportion of participants passing the initial positional setup and position verification check (e.g., CBCT/IGRT alignment) prior to the first fraction delivery on the treatment couch.

At the first fraction of radiotherapy delivery (Day 1 of treatment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Xiaohui Zhao, MD、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月9日

初级完成 (估计的)

2029年2月1日

研究完成 (估计的)

2029年2月28日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SYSKY-2026-406-03

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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