CirrhosisNCT06205992
3D-MRE and 2D-MRE for Assessing Cirrhosis and Portal Hypertension
An observational study of Cirrhosis and Liver Portal Hypertension, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Liver Portal Hypertension
- What is being tested?
- 3D-MRE, HVPG and 2D-MRE
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yu Shi contact
Zhiying Wang contact
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Yu Shi, MD, +8618940259980, 18940259980@163.com
About this study
Official title: Three-dimensional MR Elastography and Two-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension：A Prospective Multicenter Study
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.
Read the detailed description
China suffers the heaviest burden of liver disease in the world. The number of chronic liver disease is more than 400 million. Either viral-related hepatitis, alcoholic hepatitis, or metabolic-related fatty hepatitis, etc. may progress to cirrhosis, which greatly threatens public health. Portal hypertension is a critical risk factor that correlates with clinical prognosis of patients with cirrhosis. According to the Consensus on clinical application of hepatic venous pressure gradient in China (2018), hepatic venous pressure gradient (HVPG) greater than 10,12,16,20 mmHg correspondingly predicts different outcomes of patients with cirrhosis portal hypertension. It is of great significance to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis. As a universal gold standard for diagnosing and monitoring portal hypertension, HVPG remains limitation for clinical application due to its invasiveness. How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of HVPG is an important general problem in the management of portal hypertension in cirrhosis. MR elastography allows for basic viscoelastic modeling of tissue, partitioning the complex shear modulus intoelastic components (eg, storage modulus) and viscous components (eg, lossmodulus and damping ratio [DR]). In previous studies, scholars have studied 2d MR elastography in cirrhosis to identify specific hepatic pathophysiologic interrelations. However, these mechanical properties of tissue measured with use of 3D MR elastography have yet to be investigated in cirrhosis to identify specific hepatic pathophysiologic interrelations. The investigators hypothesize that these mechanical properties might be valid presumptive surrogates of cirrhosis and portal hypertension, perhaps capable of supplanting liver biopsy or other invasive diagnostic interventions. This project aims 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
- Being tested
- 3D-MRE, HVPG, 2D-MRE
- Keywords
- 3D-MRE, 2D-MRE, HVPG
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-MREDevice
All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.
HVPGDevice
HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
2D-MREDevice
All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.
HVPGDevice
HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental group was set to develop the novel non-invasive model for virtual HVPG using 3d-MRE Receives: Device: 3D-MRE; Device: HVPG | |
| Control group | Control group was set to develop the novel non-invasive model for virtual HVPG using 2d-MRE Receives: Device: 2D-MRE; Device: HVPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start16 Aug 2022
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Shengjing 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Shi, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205992
- Sponsor's protocol ID
- ShengjingH2206
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34374594Yu 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.
PubMed 35492878
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional MR Elastography and Two-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension：A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06205992
- Acronym / sponsor ID
- ShengjingH2206
- Conditions
- Cirrhosis, Liver Portal Hypertension
- Keywords
- 3D-MRE, 2D-MRE, HVPG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jan 2024 (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.
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.
Detailed description
China suffers the heaviest burden of liver disease in the world. The number of chronic liver disease is more than 400 million. Either viral-related hepatitis, alcoholic hepatitis, or metabolic-related fatty hepatitis, etc. may progress to cirrhosis, which greatly threatens public health. Portal hypertension is a critical risk factor that correlates with clinical prognosis of patients with cirrhosis. According to the Consensus on clinical application of hepatic venous pressure gradient in China (2018), hepatic venous pressure gradient (HVPG) greater than 10,12,16,20 mmHg correspondingly predicts different outcomes of patients with cirrhosis portal hypertension. It is of great significance to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis. As a universal gold standard for diagnosing and monitoring portal hypertension, HVPG remains limitation for clinical application due to its invasiveness. How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of HVPG is an important general problem in the management of portal hypertension in cirrhosis. MR elastography allows for basic viscoelastic modeling of tissue, partitioning the complex shear modulus intoelastic components (eg, storage modulus) and viscous components (eg, lossmodulus and damping ratio [DR]). In previous studies, scholars have studied 2d MR elastography in cirrhosis to identify specific hepatic pathophysiologic interrelations. However, these mechanical properties of tissue measured with use of 3D MR elastography have yet to be investigated in cirrhosis to identify specific hepatic pathophysiologic interrelations. The investigators hypothesize that these mechanical properties might be valid presumptive surrogates of cirrhosis and portal hypertension, perhaps capable of supplanting liver biopsy or other invasive diagnostic interventions. This project aims 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Device: 3D-MRE, Device: HVPGExperimental group was set to develop the novel non-invasive model for virtual HVPG using 3d-MRE |
| Control group | – | Device: 2D-MRE, Device: HVPGControl group was set to develop the novel non-invasive model for virtual HVPG using 2d-MRE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| 3D-MREAll imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil. | Device | Experimental group |
| HVPGHVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures | Device | Experimental group |
| 2D-MREAll imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil. | Device | Control group |
| HVPGHVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures | Device | Control group |
Primary outcome
Accuracy of the features of 3D-MRE and 2D-MRE for assessing portal hypertension in cirrhosis.
Time frame: 12 months
WIth HVPG as reference standand, the overall diagnostic perforemace (accuracy) for cirrhosis and portal hypertension of 3D-MRE and 2D-MRE was compared.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 34374594Shi 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.
- Background: PubMed 35492878Yu 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.
- 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.
Yu Shi contact
Zhiying Wang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Liver Portal Hypertension, run by Shengjing Hospital at 1 site 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Shi (18940259980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the features of 3D-MRE and 2D-MRE for assessing portal hypertension in cirrhosis. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06205992, which also lists 2 linked publications.
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 9 Feb 2026.