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NCT07922902Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Nov 2026

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Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
62 (estimated)
First submitted
2 Nov 2026
Start date
9 Nov 2026
Primary completion date
1 Feb 2029
Lead sponsor
zhaoxiaohui
NCT number
NCT07922902

What you commit to

  • Study type: Interventional
  • Planned participants: 62
  • From 9 Nov 2026 to the primary completion date, 1 Feb 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with a confirmed cancer who need radiotherapy as their main or follow-up treatment. It tests an AI system that outlines the radiation target and plans the treatment.

Sex
All sexes can join.
Disease stage
A cancer confirmed by pathology that needs definitive or adjuvant radiotherapy.

Main reasons for not taking part

  • Incomplete clinical, imaging, or follow-up data
  • More than one primary cancer
  • Radiotherapy planned as salvage or palliative treatment

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients scheduled for salvage or palliative radiotherapy.

Other illness

  • Presence of multiple primary malignancies.

Other

  • Incomplete clinical, imaging, or follow-up data.

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhouChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.