Brief Summary

Hepatocellular carcinoma (HCC) is a common malignancy in China with a high mortality rate. Its early recurrence and long-term prognosis are closely associated with tumor aggressiveness. Microvascular invasion (MVI), defined as the presence of tumor cells within small branches of the portal or hepatic veins, is a key indicator of malignant biological behavior in HCC. Clinically, MVI is strongly correlated with postoperative early recurrence and serves as an important factor in determining surgical margin extension, adjuvant therapy, and postoperative management strategies. At present, definitive diagnosis of MVI still relies on postoperative pathological examination, and stable, effective preoperative assessment methods are lacking. Although some studies have attempted to predict MVI using preoperative imaging features, their clinical translation remains limited by poor generalizability, weak interpretability, and insufficient cross-center adaptability. This study aims to leverage multiphase preoperative CT imaging, artificial intelligence techniques, and clinical prior knowledge to develop a high-performance, generalizable, and interpretable computer-aided diagnostic system for preoperative prediction of HCC-MVI. An observational, prospective evaluation will be conducted to assess system performance and to facilitate the clinical translation of intelligent diagnostic technologies in real-world practice.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

400

participants targeted

Target at P75+ for all trials

Timeline

16mo left

Started Sep 2025

Geographic Reach

1 country

19 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Progress34%

Sep 2025Sep 2027

First Submitted

Initial submission to the registry

August 28, 2025

Completed

4 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed

11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 12, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 28, 2025

Last Update Submit

September 5, 2025

Conditions

Hepatocellular Carcinoma (HCC)Microvascular Invasion (MVI)

Keywords

Hepatocellular CarcinomaMicrovascular InvasionComputer-Aided Diagnosis SystemArtificial IntelligenceMedical ImageMultimodal Model

Outcome Measures

Primary Outcomes (2)

Area Under the Receiver Operating Characteristic Curve (AUC)
The AUC will be calculated by comparing CAD system predictions with the reference standard of postoperative pathological diagnosis of microvascular invasion in hepatocellular carcinoma.
Within 1 month after surgery
Accuracy
Accuracy will be defined as the proportion of correctly classified cases (both MVI-positive and MVI-negative) by the CAD system compared with postoperative pathology.
Within 1 month after surgery

Secondary Outcomes (3)

Sensitivity
Within 1 month after surgery
Specificity
Within 1 month after surgery
Calibration
Within 1 month after surgery

Other Outcomes (2)

Processing Time
Within 1 month after surgery
Physician Confidence Score
Within 1 month after surgery

Study Arms (19)

Peking Union Medical College Hospital

patients aged 18 years and older who undergo surgical resection for hepatocellular carcinoma with available pathological evaluation of microvascular invasion. We will collect preoperative multiphase CT images, clinical characteristics, and pathological outcomes.