Automated Radiation Target Contouring and Treatment Planning Via RATA: A Multi-Center RCT
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Xiaohui Zhao, MD
- 電話番号:+86-13828491190
- メール:zhaoxh27@mail.sysu.edu.cn
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510120
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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コンタクト:
- Xiaohui Zhao, MD
- 電話番号:+86-13828491190
- メール:zhaoxh27@mail.sysu.edu.cn
-
主任研究者:
- Xiaohui Zhao, MD
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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. |
|
アクティブコンパレータ: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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Closed-Loop Workflow Duration
時間枠: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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Acceptance Rate of Treatment Plans
時間枠:At plan evaluation prior to treatment delivery (up to 1 day)
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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
時間枠: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)
|
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Contouring Accuracy Metrics and Dosimetric Parameters
時間枠: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)
|
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First Setup Verification Pass Rate
時間枠:At the first fraction of radiotherapy delivery (Day 1 of treatment)
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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)
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Xiaohui Zhao, MD、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SYSKY-2026-406-03
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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