AI-Driven Quantitative Decision and Surgical Planning System for Liver Cancer

NCT07042841 | Enrolling By Invitation

• 1 other identifier: 25293-0-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer, Adult

Keywords

Liver Cancer; Artificial Intelligence; Computer-Aided Diagnosis; Multimodal Image Fusion; Pathology-CT Registration

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

HCC Positive Group

HCC-positive with liver lesion

HCC Negative Lesion Group

HCC-negative with liver lesion

Non-Lesion Control Group

No liver lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \. Dynamic contrast-enhanced CT scan of the liver is available. 2. Age ≥ 18 years. 3. CT image slice thickness ≤ 5 mm. 4. An official CT report is available. 5. Meets at least one of the following subcategories:HCC-positive with liver lesion: CT report suggests suspected hepatocellular carcinoma (HCC), and complete hospitalization records are available to assess CNLC staging (including performance status, Child-Pugh classification, and extrahepatic metastasis). HCC-negative with liver lesion: CT report indicates at least one liver-occupying lesion, but not suspected to be HCC. No liver lesion: CT report indicates no liver-occupying lesion.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Shuo Jin, PhD

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 29, 2025
• Study Start: June 30, 2015
• Primary Completion: December 30, 2024
• Study Completion (Estimated): October 30, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)