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RECRUITING
NCT07538882

AI-Assisted Staging and Treatment Decision-Making for Hepatocellular Carcinoma

Sponsor: Beijing Tsinghua Chang Gung Hospital

View on ClinicalTrials.gov

Summary

The precise treatment of primary hepatocellular carcinoma (HCC) highly depends on accurate disease staging (CNLC, TNM, BCLC) and scientific treatment decision-making, which necessitate the integration of both imaging and clinical baseline data. This study prospectively recruits HCC patients and clinical physicians across different hospital tiers to evaluate the clinical value of a self-developed artificial intelligence (AI) model in assisting multi-dimensional comprehensive assessment and treatment decision-making. Utilizing a Multi-Rater Multi-Case (MRMC) crossover balanced design, the study compares the accuracy of clinical evaluations performed by physicians under "unassisted (without AI)" versus "AI-assisted" conditions. A key focus is to explore whether AI can significantly enhance the comprehensive assessment capabilities of physicians in primary/secondary care hospitals, thereby prospectively reducing diagnostic and therapeutic heterogeneity across different institutional levels.

Official title: A Prospective, Randomized, Controlled, Crossover Study of Artificial Intelligence-Assisted Multi-Dimensional Staging and Treatment Decision-Making for Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

108

Start Date

2026-04-13

Completion Date

2026-05-20

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Unassisted Independent Evaluation

Physicians independently evaluate the HCC cases and provide staging and treatment decisions using only complete clinical baseline data and imaging data, without any assistance from the AI model.

DIAGNOSTIC_TEST

AI-Assisted Evaluation

Physicians evaluate the HCC cases and provide final staging and treatment decisions after reviewing the initial predictions and related evidence generated by the self-developed artificial intelligence (AI) model, alongside the clinical baseline and imaging data.

Locations (1)

Beijing Tsinghua Changgung Hospital

Beijing, Changping, China