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This study aims to develop and validate an integrated AI-powered system for liver cancer that includes intelligent tumor boundary detection, micro-metastasis prediction, staging, treatment decision-making, and surgical planning. The system builds upon prior 3D reconstructions of liver, vessels, and bile ducts. In a retrospective multi-center, self-controlled, fully crossed multi-reader multi-case clinical trial, the researchers will compare diagnostic accuracy, staging, and planning performance between AI-assisted reads and conventional reads using CT images and pathological gold standards.
Background Precise tumor boundary definition on preoperative imaging is often unreliable, and regional disparities in healthcare resources limit personalized decision-making. Currently, no comprehensive AI system integrates imaging, pathology, staging, decision, and surgical planning for liver cancer.
Objectives 1: Develop a pathological-tumor-boundary evaluation system based on whole-slide pathology and CT registration. 2: Build models to predict tumor boundary and satellite micro-metastasis from CT images using deep learning and radiomics. 3: Integrate staging modules (Child-Pugh, ECOG-PS, CNLC/BCLC) and generate individualized treatment recommendations. 4: Create a surgical planning platform that calculates liver remnant volume, vascular invasion metrics, anatomical variants, and performs virtual resections. 5: Validate the system in a retrospective self-controlled multi-reader multi-case study across multiple centers.
Methods Tumor boundary & micro-metastasis prediction: Register 3D whole-slide pathology of resected specimens to preoperative CT using multiplanar reconstruction; pathologists annotate tumor and satellite lesions; train deep-learning models to predict pathological boundaries and micro-metastasis regions. Validate in 100 cases with pathological CT comparison. Decision modules: Automatically compute Child-Pugh and ECOG-PS scores from labs and records; integrate with tumor metrics and PV invasion to achieve CNLC/BCLC staging and generate decision suggestions. Surgical planning: Calculate functional liver volume requirements per consensus, estimate standard liver volume (SLV), tumor-bearing segment volume, future liver remnant (FLR/SLV), flag unsafe resections; analyze vascular invasion level, length, and perfusion territory; detect portal/bile anatomical variants for injury warnings; perform virtual anatomical and non-anatomical resections with margin control and risk predictions. Clinical validation: Conduct a retrospective, fully-crossed multi-reader multi-case trial: randomized CT reading by surgeons/radiologists with and without software assistance, separated by washout periods. Evaluate primary endpoints: AFROC-AUC for lesion detection, LROC-AUC for HCC diagnosis. Secondary endpoints include sensitivity, specificity, ROC-AUC, diagnostic consistency (Kappa), size/count accuracy (<5% error), staging concordance, and reading time.
Study population Adult participants with dynamic contrast-enhanced liver CT, including HCC-positive, HCC-negative lesion-positive, and lesion-negative cases. Exclude cases with incomplete liver imaging, heavy noise, prior liver resection, or unreadable CT.
Statistical analysis Compare AUCs between AI-assisted and manual reading; non-inferiority established if lower bound of 95% CI > 0. Secondary metrics include sensitivity, specificity, consistency, reading time, and staging accuracy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC Positive Group | HCC-positive with liver lesion | ||
| HCC Negative Lesion Group | HCC-negative with liver lesion | ||
| Non-Lesion Control Group | No liver lesion |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of the intelligent liver cancer diagnosis and surgical planning system | The diagnostic accuracy will be evaluated by comparing the system's prediction of tumor boundaries and microvascular invasion with pathological gold standards. | At the time of surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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This study aims to include adult patients (≥18 years old) who have undergone dynamic contrast-enhanced CT imaging of the liver. The population will consist of three groups:
HCC-positive group (Group 1): Patients with liver lesions diagnosed as suspected hepatocellular carcinoma (HCC) based on CT imaging reports, and with complete clinical records for assessment of CNLC staging, Child-Pugh score, and extrahepatic metastasis.
HCC-negative with liver lesion group (Group 2): Patients with liver lesions identified on CT imaging but without HCC diagnosis, and without clear evidence of extrahepatic metastasis.
Non-lesion control group (Group 3): Patients with no liver lesions identified on CT imaging, serving as the control group.
All participants will have a CT imaging slice thickness of ≤5 mm, and must be capable of providing complete imaging reports and medical records. The study will target approximately 300 participants across these groups.
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| Name | Affiliation | Role |
|---|---|---|
| Shuo Jin, PhD | Beijing Tsinghua Chang Gung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Chang Gung Hospital | Beijing | Beijing Municipality | 102218 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |