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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors

NCT06018142

Neoplasms, Liver Neoplasms Malignant Neoplasm Metastasis +2 more

UNKNOWN

A Trial on Contrast-enhanced Ultrasound Versus Conventional Ultrasound Guided Biopsy of Liver Neoplasms

NCT02413437

Liver Neoplasms

UNKNOWN NA

The Development of Quantitative Ultrasound Imaging Software Platform

NCT05836246

Chronic Liver Disease Thyroid Disease Benign Breast Disease +2 more

ENROLLING_BY_INVITATION

Clinical Research on a Novel Deep-learning Based System in Pancreatic Mass Diagnosis

NCT04607720

Solid Pancreatic Masses

UNKNOWN NA

Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

NCT05748106

Image-Guided Biopsies and/or Ablations

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HCC - Hepatocellular Carcinoma Microvascular Invasion (MVI)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chinese PLA General Hospital Cohort

Patients from Chinese PLA General Hospital (northern China) after surgical treatment

the MAPUSE model

Intervention Type DIAGNOSTIC_TEST

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

the MAPUSE model

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

the MAPUSE model

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.