- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06923254
7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy
April 4, 2025 updated by: Xin Lou, Chinese PLA General Hospital
This clinical trial study aims to detect the imaging characteristics of patients with hepatic encephalopathy (HE) using 7-Tesla (7T) magnetic resonance imaging (MRI).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Tang
- Phone Number: +8618001184224
- Email: jessietang301@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Chinese PLA General Hospital
-
Contact:
- Jing Tang
- Phone Number: +8618001184224
- Email: jessietang301@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients with hepatic encephalopathy
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Contraindications to MRI.
- Patients with cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
7.0T Research
With the advantages of 7.0TMRI, we detect the imaging characteristics of patients with hepatic encephalopathy (HE).
|
7.0T MRI-Scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between spectral features of clinical variables and spectral features of imaging.
Time Frame: 5 years
|
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.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Xin Lou, Chinese PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 3, 2025
Primary Completion (Estimated)
December 24, 2029
Study Completion (Estimated)
December 24, 2030
Study Registration Dates
First Submitted
April 4, 2025
First Submitted That Met QC Criteria
April 4, 2025
First Posted (Actual)
April 11, 2025
Study Record Updates
Last Update Posted (Actual)
April 11, 2025
Last Update Submitted That Met QC Criteria
April 4, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hepatic encephalopathy-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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