An interventional study of RATA (Radiotherapy Treatment Multi-Agent Assistant) System and Standard Radiotherapy Planning Workflow in Cancer, Malignant Neoplasms and Radiotherapy, sponsored by zhaoxiaohui. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by zhaoxiaohui · Not applicable, Interventional, and Health services research
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 62 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with zhaoxiaohui as lead sponsor.
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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.
Exclusion Criteria:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: RATA (Radiotherapy Treatment Multi-Agent Assistant) System
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.
Other: Standard Radiotherapy Planning Workflow
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.
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.
Total Closed-Loop Workflow Duration
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.
Time frame: At the time of simulation and treatment planning for each participant (up to 1 day)
Clinical Acceptance Rate of Treatment Plans
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.
Time frame: At plan evaluation prior to treatment delivery (up to 1 day)
Planning Time and Workload Reduction Rate
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.
Time frame: At plan evaluation prior to treatment delivery (up to 1 day)
Contouring Accuracy Metrics and Dosimetric Parameters
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.
Time frame: At plan evaluation prior to treatment delivery (up to 1 day)
First Setup Verification Pass Rate
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.
Time frame: At the first fraction of radiotherapy delivery (Day 1 of treatment)
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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