3D-MRE and 2D-MRE for Assessing Cirrhosis and Portal Hypertension

NCT06205992 | Recruiting DMC

• 1 other identifier: ShengjingH2206
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. We plan to compare the ability of three demensional-magnetic resonance elastography (3D-MRE) to two demensional-magnetic resonance elastography (2D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis.

Conditions

Cirrhosis; Liver Portal Hypertension

Keywords

3D-MRE; 2D-MRE; HVPG

Outcome Measures

Primary Outcomes (1)

• Accuracy of the features of 3D-MRE and 2D-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 and 2D-MRE was compared.

  12 months

Study Arms (2)

Experimental group

Experimental group was set to develop the novel non-invasive model for virtual HVPG using 3d-MRE

Device: 3D-MRE; Device: HVPG

Control group

Control group was set to develop the novel non-invasive model for virtual HVPG using 2d-MRE

Device: 2D-MRE; Device: HVPG

Interventions

3D-MRE DEVICE

All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.

Experimental group

2D-MRE DEVICE

All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.

Control group

HVPG DEVICE

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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, 3D-MRE and 2D-MRE should be enrolled

You may qualify if:

• age \> 18 years old
• confirmed cirrhosis (laboratory, imaging and clinical symptoms)
• with 3D-MRE and 2D-MRE within 1 month prior to HVPG measurement
• written informed consent

You may not qualify if:

• any previous liver or spleen surgery
• liver cancer; chronic acute liver failure
• acute portal hypertension
• unreliable HVPG, 3D-MRE or 2D-MRE results due to technical reasons
• with liver interventional therapy between HVPG and MRE

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, 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: 34374594 BACKGROUND

• 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: 35492878 BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu Shi

CONTACT

18940259980@163.com

Zhiying Wang

CONTACT

wangzhiying990816@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: January 4, 2024
• First Posted: January 16, 2024
• Study Start: August 16, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Locations

CN (1)