HCC - Hepatocellular CarcinomaMAPUSENCT06760494
Microvascular Invasion Artificial Intelligence Prediction Via Contrast-enhanced Ultrasound With Explainability
An observational study of HCC - Hepatocellular Carcinoma and Microvascular Invasion (MVI), run by Chinese PLA General Hospital at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Microvascular Invasion (MVI)
- What is being tested?
- the MAPUSE model
- How many people
- 250 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2023to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent surgical treatment for HCC
Who may be able to join
- 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.
Who cannot join
- Unqualified CEUS images.
- Missing surgical pathological diagnosis.
- Lesions underwent local treatments.
- Non-HCC diagnosis
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chinese PLA General Hospital
Beijing, 100853
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: 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.
Read the 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.
- Being tested
- the MAPUSE model
- Keywords
- hepatocellular carcinoma, microvascular invasion, contrast-enhanced ultrasound, deep learning
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the MAPUSE modelDiagnostic test
Using the MAPUSE model to predict MVI status before surgical resection for HCC patients
| Study group | Role | What they receive |
|---|---|---|
| Chinese PLA General Hospital Cohort | Patients from Chinese PLA General Hospital (northern China) after surgical treatment Receives: Diagnostic Test: the MAPUSE model | |
| 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 Receives: Diagnostic Test: the MAPUSE model |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under operating characteristic curves (AUC)
the area under operating characteristic curves (AUC) to evaluate the performance of MAPUSE model in predicting MVI in HCC patients
Measured: From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)
Secondary outcomes (3)
ACC (accuracy)
The ratio of the number of samples correctly predicted by the model to the total number of samples
Measured: From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)
Specificity
Proportion of all patients without MVI who are predicted negative by MAPUSE
Measured: From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)
Sensitivity
The proportion of patients with MVI that MAPUSE correctly identifies
Measured: From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Nov 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Chuan Pang, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760494
- Sponsor's protocol ID
- MAPUSE
- Other IDs
- 92159305, 82030047, 82325027
- Acronym
- MAPUSE
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Microvascular Invasion in HCC Using Spatiotemporal Radiomics of Contrast-enhanced Ultrasound: a Deep Learning Model With Transcriptomics Correlation
- ClinicalTrials.gov ID
- NCT06760494
- Acronym / sponsor ID
- MAPUSE / MAPUSE
- Keywords
- hepatocellular carcinoma, microvascular invasion, contrast-enhanced ultrasound, deep learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese PLA General Hospital Cohort | – | Diagnostic Test: the MAPUSE modelPatients from Chinese PLA General Hospital (northern China) after surgical treatment |
| the First Affiliated Hospital of Sun Yat-sen University Cohort | – | Diagnostic Test: the MAPUSE modelPatients from the First Affiliated Hospital of Sun Yat-sen University (southern China) after surgical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent surgical treatment for HCC
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Unqualified CEUS images.
- Missing surgical pathological diagnosis.
- Lesions underwent local treatments.
- Non-HCC diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the MAPUSE modelUsing the MAPUSE model to predict MVI status before surgical resection for HCC patients | Diagnostic test | Chinese PLA General Hospital Cohort, the First Affiliated Hospital of Sun Yat-sen University Cohort |
Primary outcome
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
3 secondary outcomes
ACC (accuracy)
Time frame: 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)
Sensitivity
Time frame: From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuan Pang principal investigator
Chinese PLA General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma and Microvascular Invasion (MVI), run by Chinese PLA General Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under operating characteristic curves (AUC) (time frame: From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.