Actively Recruiting

Age: 18Years - 75Years
All Genders
ID05475015

Three-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension (CHESS2206): A Prospective Multicenter Study

Led by Shengjing Hospital · Updated on 2026-02-09

150

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

S

Shengjing Hospital

Lead Sponsor

Z

Zhongda Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new, non-invasive method using three-dimensional magnetic resonance elastography (3D-MRE) to predict hepatic venous pressure gradient (HVPG) in patients with cirrhosis, portal hypertension, or advanced chronic liver disease. This study aims to establish a risk stratification system to better manage portal hypertension, a critical factor affecting the prognosis of these liver conditions. The trial is observational and focuses on improving diagnosis without invasive procedures like liver biopsy or traditional HVPG measurement. The study involves two groups: a training cohort to develop the new 3D-MRE model for virtual HVPG prediction, and a validation cohort to confirm the model's accuracy in different patients under similar conditions. Imaging is done using a 3.0-T MRI system with a phased-array body coil, while HVPG measurements are performed by skilled interventional radiologists following standard procedures. Participants undergo both assessments within one month. During the 12-month study, participants will have their portal hypertension assessed through the features of 3D-MRE and HVPG readings. Researchers will analyze the accuracy of 3D-MRE to predict portal hypertension levels. Participants provide informed consent and meet age and health criteria. The study includes monitoring to ensure reliable imaging and measurement results, with exclusion of those with conditions or treatments that may affect accuracy. The total participation involves these diagnostic steps, with no treatment interventions administered.

CONDITIONS

Brief Title

3D-MRE for Assessing Cirrhosis, Advanced Chronic Liver Disease and Portal Hypertension

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Provided written informed consent
  • Confirmed advanced chronic liver disease from any liver disease cause
  • Scheduled for hepatic venous pressure gradient (HVPG) measurement with 3D-MRE performed within one month prior
Not Eligible

You will not qualify if you...

  • Presence of hepatic or extrahepatic cancers or large liver or spleen diseases affecting MRE
  • Contraindications to MR imaging or HVPG measurement
  • Previous liver or splenic surgery that affects MRE accuracy
  • Use of nonselective beta-blockers (NSBB) between MRE and HVPG measurements
  • Invalid or unreliable HVPG or MRE results
  • Biliary obstruction or dilation seen on MR images

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 1 month

Participants undergo 3D magnetic resonance elastography (3D-MRE) and hepatic venous pressure gradient (HVPG) measurement to assess liver condition and portal hypertension.

1 to 2 visits depending on scheduling of 3D-MRE and HVPG

Long-term Monitoring

Duration - 12 months

Participants are monitored for up to 12 months to evaluate the accuracy of 3D-MRE in assessing portal hypertension in cirrhosis.

Follow-up visits as scheduled during the 12 months

Trial Site Locations

Total: 1 location

1

Shengjing Hospital

Shenyang, Liaoning, China, 210000

Actively Recruiting

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Research Team

Y

Yifei Huang, M.D.

Y

Yu Shi, Prof.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

An imaging-based artificial intelligence model for non-invasive grading of hepatic venous pressure gradient in cirrhotic portal hypertension.

Qian Yu, Yifei Huang, Xiaoguo Li...

https://pubmed.ncbi.nlm.nih.gov/35492878