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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06760494
Acronym
MAPUSE
Enrollment
250
Registered
2025-01-06
Start date
2023-11-01
Completion date
2024-05-30
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC - Hepatocellular Carcinoma, Microvascular Invasion (MVI)

Keywords

hepatocellular carcinoma, microvascular invasion, contrast-enhanced ultrasound, deep learning

Brief 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.

Interventions

DIAGNOSTIC_TESTthe MAPUSE model

Using the MAPUSE model to predict MVI status before surgical resection for HCC patients

Sponsors

Chinese Academy of Sciences
CollaboratorOTHER_GOV
Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \>18 years old. 2. The HCC diagnosis and the presence of MVI were confirmed by surgical pathology. 3. Complete and clear CEUS videos obtained within two weeks preoperatively.

Exclusion criteria

1. Unqualified CEUS images. 2. Missing surgical pathological diagnosis. 3. Lesions underwent local treatments. 4. Non-HCC diagnosis

Design outcomes

Primary

MeasureTime frameDescription
area under operating characteristic curves (AUC)From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)the area under operating characteristic curves (AUC) to evaluate the performance of MAPUSE model in predicting MVI in HCC patients

Secondary

MeasureTime frameDescription
ACC (accuracy)From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)The ratio of the number of samples correctly predicted by the model to the total number of samples
SpecificityFrom preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)Proportion of all patients without MVI who are predicted negative by MAPUSE
SensitivityFrom preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)The proportion of patients with MVI that MAPUSE correctly identifies

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026