NCT06760494

Microvascular Invasion Artificial Intelligence Prediction Via Contrast-enhanced Ultrasound With Explainability

Prediction of Microvascular Invasion in HCC Using Spatiotemporal Radiomics of Contrast-enhanced Ultrasound: a Deep Learning Model With Transcriptomics Correlation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An artificial intelligence (AI) model to predict MVI of HCC using contrast-enhanced ultrasound was constructed. This model also has biological explainability. The investigators named it as MAPUSE (MVI AI prediction via contrast-enhanced ultrasound with explainability). The goal of MAPUSE study is to prospectively test the performance of MAPUSE model on MVI prediction and its biological correlation in different geographical areas of China.

Detailed description

The presence of microvascular invasion (MVI) in hepatocellular carcinoma (HCC) is a critical prognostic indicator, but its preoperative diagnosis remains challenging. Contrast-enhanced ultrasound (CEUS), with its dynamic microvascular imaging capability, holds promise in prediction of MVI. The investigators constructed an artificial intelligence (AI) model to predict MVI using contrast-enhanced ultrasound. This model also has biological explainability. We named it as MAPUSE (MVI AI prediction via contrast-enhanced ultrasound with explainability). The goal of MAPUSE study is to prospectively test the performance of MAPUSE model on MVI prediction and its biological correlation in different geographical areas of China. The performance of MAPUSE is to be tested in two prospective testing cohorts from two centers in southern and northern China. Before surgery, patient CEUS videos will be collected and analysed by MAPUSE model to generate an MVI risk score. According to the postoperative pathological diagnosis of MVI (golden criterion), the result of MAPUSE will be evaluated. Parameters include area under curve (AUC), accuracy (ACC), sensitivity, specificity and F1-score.

Conditions

• HCC - Hepatocellular Carcinoma
• Microvascular Invasion (MVI)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	the MAPUSE model	Using the MAPUSE model to predict MVI status before surgical resection for HCC patients

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2025-01-06
• Last updated: 2025-01-06

Locations

2 sites across 1 country: China