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Clinical Trials in China / NCT07658586
Active, not recruiting Observational

AI Multimodal Model for Liver Cancer Diagnosis and Prognosis

NCT07658586 · tracked via the Priya Life Science China tracker
Sponsor
Guangxi Medical University
Phase
Observational
Started
2025-12-01
Last updated
2026-07-01

Condition(s) studied

Liver CancerHepatocellular CarcinomaIntrahepatic Cholangiocarcinoma (Icc)

Study summary

This study aims to develop a comprehensive artificial intelligence model system integrating preoperative multimodal data (CT/MRI imaging, clinical laboratory data, and radiology report text) to achieve two core objectives. First, to develop a multimodal fusion diagnostic model for non-invasive and accurate preoperative differentiation of liver cancer subtypes, including distinguishing benign from malignant lesions and differentiating hepatocellular carcinoma from intrahepatic cholangiocarcinoma. Second, to develop a prognostic prediction model for patients with confirmed liver cancer undergoing radical surgery to assess postoperative progression-free survival and overall survival. This is a multicenter retrospective cohort study with an anticipated sample size of ≥600 patients. Model performance will be evaluated using AUC, accuracy, sensitivity, specificity, C-index, and calibration curves. Subgroup analysis will be conducted based on whether patients received neoadjuvant therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: -Diagnostic Model Cohort: * Age ≥18 years * Underwent preoperative contrast-enhanced CT or MRI for clinically suspected liver space-occupying lesion * Have complete preoperative clinical laboratory data * Have complete original CT/MRI imaging data and radiology reports * Have definite pathological diagnosis from surgery or biopsy as gold standard Prognostic Prediction Model Cohort (selected from diagnostic cohort): * Meet all diagnostic cohort inclusion criteria * Pathologically confirmed liver cancer * Underwent radical hepatectomy * Have complete preoperative multimodal data (CT/MRI imaging, clinical laboratory data, radiology reports) * Have complete postoperative follow-up data to determine progression-free survival and overall survival endpoints and time (minimum follow-up of 24 months) Exclusion Criteria: * · Key clinical, imaging, or pathological data severely missing or incomplete * Preoperative CT or MRI images of poor quality or missing sequences, unable to perform reliable image analysis * Prior local treatment for the target liver lesion, unless clearly recorded as neoadjuvant therapy before surgery * Concurrent other malignant tumors * Lost to follow-up or follow-up data cannot meet endpoint determination requirements

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Guangxi Medical University First Affiliated Hospital Nanning Guangxi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07658586 on ClinicalTrials.gov ↗ ← All trials in China