NCT06923254

Brief Summary

This clinical trial study aims to detect the imaging characteristics of patients with hepatic encephalopathy (HE) using 7-Tesla (7T) magnetic resonance imaging (MRI).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Apr 2025Dec 2030

Study Start

First participant enrolled

April 3, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2030

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

4.7 years

First QC Date

April 4, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

Hepatic EncephalopathyfMRI

Outcome Measures

Primary Outcomes (1)

  • Functional connectivity and structural alterations between individuals with different subtypes of HE and healthy subjects.

    Functional connectivity calculation is mainly based on the BOLD sequence, which is used to describe the degree of connectivity between different brain regions and reflect the functional activity of the brain. Gray matter (GM) morphological destruction, cortical thickness, and subcortical nuclear volume in patients with hepatic encephalopathy were analyzed based on structural magnetic resonance imaging(sMRI).

    5 years

Secondary Outcomes (1)

  • Correlation between spectral features of clinical variables and spectral features of imaging.

    5 years

Study Arms (1)

7.0T Research

With the advantages of 7.0TMRI, we detect the imaging characteristics of patients with hepatic encephalopathy (HE).

Other: 7.0T MRI-Scan

Interventions

7.0T MRI-Scan

7.0T Research

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hepatic encephalopathy

You may qualify if:

  • Patients with clinical suspected or diagnosed hepatic encephalopathy according to relevant guidelines.The patient's education level is above primary school level.
  • Regular follow-up.

You may not qualify if:

  • Contraindications to MRI.
  • Patients with cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Xin Lou

    Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Department of Radiology

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 11, 2025

Study Start

April 3, 2025

Primary Completion (Estimated)

December 24, 2029

Study Completion (Estimated)

December 24, 2030

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations