NCT05475015

Brief Summary

How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of hepatic venous pressure gradient (HVPG) is an important general problem in the management of portal hypertension in cirrhosis or advanced chronic liver disease. We plan to investigate the ability of three demensional-magnetic resonance elastography (3D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis or advanced chronic liver disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Aug 2022Dec 2026

First Submitted

Initial submission to the registry

July 19, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

August 16, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 9, 2026

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

July 19, 2022

Last Update Submit

February 5, 2026

Conditions

Portal HypertensionAdvanced Chronic Liver DiseaseCirrhosis, Liver

Keywords

3D-MREHVPGadvanced chronic liver disease

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the features of 3D-MRE for assessing portal hypertension in cirrhosis.

    WIth HVPG as reference standand, the overall diagnostic perforemace (accuracy) for cirrhosis and portal hypertension of 3D-MRE was assessed.

    12 months

Study Arms (2)

Training cohort

Training cohort was set to develop the novel non-invasive model for virtual HVPG

Device: 3D-MREDevice: HVPG

Validation cohort

Validation cohort was set to validate the novel non-invasive model for virtual HVPG in different people in same environments

Device: 3D-MREDevice: HVPG

Interventions

3D-MREDEVICE

All imaging studies were performed by using a 3.0-T MRI system ( GE Healthcare) with a phasedarray body coil.

Training cohortValidation cohort
HVPGDEVICE

HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures.

Training cohortValidation cohort

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with cirrhosis who received HVPG measurement and 3D-MRE should be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 210000, China

RECRUITING

Related Publications (2)

  • Shi Y, Qi YF, Lan GY, Wu Q, Ma B, Zhang XY, Ji RY, Ma YJ, Hong Y. Three-dimensional MR Elastography Depicts Liver Inflammation, Fibrosis, and Portal Hypertension in Chronic Hepatitis B or C. Radiology. 2021 Oct;301(1):154-162. doi: 10.1148/radiol.2021202804. Epub 2021 Aug 10.

    PMID: 34374594BACKGROUND

  • Yu Q, Huang Y, Li X, Pavlides M, Liu D, Luo H, Ding H, An W, Liu F, Zuo C, Lu C, Tang T, Wang Y, Huang S, Liu C, Zheng T, Kang N, Liu C, Wang J, Akcalar S, Celebioglu E, Ustuner E, Bilgic S, Fang Q, Fu CC, Zhang R, Wang C, Wei J, Tian J, Ormeci N, Ellik Z, Asiller OO, Ju S, Qi X. An imaging-based artificial intelligence model for non-invasive grading of hepatic venous pressure gradient in cirrhotic portal hypertension. Cell Rep Med. 2022 Mar 15;3(3):100563. doi: 10.1016/j.xcrm.2022.100563. eCollection 2022 Mar 15.

    PMID: 35492878BACKGROUND

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yu Shi, Prof.

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

  • Shenghong Ju, Prof.

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

  • Xiaolong Qi, Prof.

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifei Huang, M.D.

CONTACT

+86 158 0000 4518huangyf1995@foxmail.com

Yu Shi, Prof.

CONTACT

+86 189 4025 998018940259980@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of department of radology

Study Record Dates

First Submitted

July 19, 2022

First Posted

July 26, 2022

Study Start

August 16, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 9, 2026

Record last verified: 2025-12

Locations

CN(1)