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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Improvement in Overall Accuracy — Up to 1 week (Assessed upon completion of all case evaluations)
  The difference in average accuracy across the 4 classification tasks between AI-assisted evaluation (experimental) and independent evaluation (control). Accuracy is determined by comparing physicians' predictions against the reference standard (Ground Truth) established by the independent expert panel

Trial sites (1)

More Beijing Tsinghua Chang Gung Hospital trials in China

Other trials for the same condition