Hepatic Encephalopathy (HE)NCT06923254
7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy
An observational study of Hepatic Encephalopathy (HE) and MRI, run by Chinese PLA General Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Encephalopathy (HE), MRI, fMRI Research
- What is being tested?
- 7.0T MRI-Scan
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2025to 24 Dec 2030
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with hepatic encephalopathy
Who may be able to join
- 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.
Who cannot join
- Contraindications to MRI.
- Patients with cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jing Tang, +8618001184224, jessietang301@163.com
About this study
This clinical trial study aims to detect the imaging characteristics of patients with hepatic encephalopathy (HE) using 7-Tesla (7T) magnetic resonance imaging (MRI).
Read the detailed description
In this study, we analyzed the imaging characteristics of HE. First, with the advantages of 7TMRI, we analyzed the differences in imaging characteristics between HE patients and the healthy, including brain functional imaging and structural imaging. Second, we analyzed the differences in imaging characteristics between different subgroups of HE patients. Finally, we analyzed the correlation between the prognostic results of HE patients after follow-up and the imaging characteristics.
- Conditions
- Hepatic Encephalopathy (HE), MRI, fMRI Research
- Being tested
- 7.0T MRI-Scan
- Keywords
- Hepatic Encephalopathy, fMRI
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.0T MRI-ScanOther
7.0T MRI-Scan
| Study group | Role | What they receive |
|---|---|---|
| 7.0T Research | With the advantages of 7.0TMRI, we detect the imaging characteristics of patients with hepatic encephalopathy (HE). Receives: Other: 7.0T MRI-Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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）.
Measured: 5 years
Secondary outcomes (1)
Correlation between spectral features of clinical variables and spectral features of imaging.
The clinical variable spectrum characteristics were constructed using the patients' medical records and test data. The distribution characteristics of clinical psychological characteristics and imaging spectrum characteristics were compared using a multidimensional matrix, and gene-imaging association analysis was used to evaluate imaging changes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start3 Apr 2025 (estimated)
- Primary completion24 Dec 2029 (estimated)
- Study completion24 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Encephalopathy (HE)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923254
- Sponsor's protocol ID
- Hepatic encephalopathy-301
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT06923254
- Acronym / sponsor ID
- Hepatic encephalopathy-301
- Conditions
- Hepatic Encephalopathy (HE), MRI, fMRI Research
- Keywords
- Hepatic Encephalopathy, fMRI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 3 Apr 2025 (estimated)
- Primary completion
- 24 Dec 2029 (estimated)
- Study completion
- 24 Dec 2030 (estimated)
- First posted
- 11 Apr 2025 (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.
This clinical trial study aims to detect the imaging characteristics of patients with hepatic encephalopathy (HE) using 7-Tesla (7T) magnetic resonance imaging (MRI).
Detailed description
In this study, we analyzed the imaging characteristics of HE. First, with the advantages of 7TMRI, we analyzed the differences in imaging characteristics between HE patients and the healthy, including brain functional imaging and structural imaging. Second, we analyzed the differences in imaging characteristics between different subgroups of HE patients. Finally, we analyzed the correlation between the prognostic results of HE patients after follow-up and the imaging characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7.0T Research | – | Other: 7.0T MRI-ScanWith the advantages of 7.0TMRI, we detect the imaging characteristics of patients with hepatic encephalopathy (HE). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatic encephalopathy
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications to MRI.
- Patients with cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease.
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 |
|---|---|---|
| 7.0T MRI-Scan7.0T MRI-Scan | Other | 7.0T Research |
Primary outcome
Functional connectivity and structural alterations between individuals with different subtypes of HE and healthy subjects.
Time frame: 5 years
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）.
1 secondary outcome
Correlation between spectral features of clinical variables and spectral features of imaging.
Time frame: 5 years
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 11 Apr 2025.
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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.
Xin Lou study chair
Chinese PLA General Hospital
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 Hepatic Encephalopathy (HE) and MRI, run by Chinese PLA General 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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 Jing Tang (+8618001184224, jessietang301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity and structural alterations between individuals with different subtypes of HE and healthy subjects. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.