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NCT Number: NCT06760494

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unqualified CEUS images.
  • Missing surgical pathological diagnosis.
  • Lesions underwent local treatments.
  • Non-HCC diagnosis

Treatment and study plan

the MAPUSE model

Diagnostic Test

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

Primary outcomes

  1. area under operating characteristic curves (AUC)

    Time frame: 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 outcomes

  1. ACC (accuracy)

    Time frame: 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

  2. Specificity

    Time frame: From 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

  3. Sensitivity

    Time frame: From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)

    The proportion of patients with MVI that MAPUSE correctly identifies

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Chinese Academy of Sciences

Registry information

Official study title

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

Acronym: MAPUSE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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