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

January 3, 2025 updated by: Ping Liang, Chinese PLA General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100853
        • Chinese PLA General Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients who underwent surgical treatment for HCC

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chinese PLA General Hospital Cohort
Patients from Chinese PLA General Hospital (northern China) after surgical treatment
Diagnostic test: the MAPUSE model
Using the MAPUSE model to predict MVI status before surgical resection for HCC patients
the First Affiliated Hospital of Sun Yat-sen University Cohort
Patients from the First Affiliated Hospital of Sun Yat-sen University (southern China) after surgical treatment
Diagnostic test: the MAPUSE model
Using the MAPUSE model to predict MVI status before surgical resection for HCC patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)
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
From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)
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
From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

Chinese Academy of Sciences

Investigators

  • Principal Investigator: Chuan Pang, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

December 28, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAPUSE
  • 82030047 (Other Identifier: The National Natural Science Foundation of China)
  • 92159305 (Other Identifier: The National Natural Science Foundation of China)
  • 82325027 (Other Identifier: The National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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