Liver Fibrosis After Liver TransplantationNCT05292885
Mp-MRI in the Diagnosis of Liver Fibrosis After Liver Transplantation
An observational study of Liver Fibrosis After Liver Transplantation and Multiparameter Magnetic Resonance Imaging, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
It is an open label observation clinical trial, all participants are liver transplant patients. The investigators deem to make a better criteria for assessing liver fibrosis after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Fibrosis After Liver Transplantation, Multiparameter Magnetic Resonance Imaging
- What is being tested?
- Gadopentetate Dimeglumine Injection
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2022to 1 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- Adult, Older adult
Study population: Patients with liver fibrosis after liver transplantation underwent percutaneous liver biopsy or FibroScan.
Who may be able to join
- Subjects aged 18 -85 years
- Patients after liver transplantation
- Patients who are going to undergo liver biopsy or ultrasonic transient elastography
- Patients voluntarily joined the study and signed informed consent
Who cannot join
- Patients with tumor
- Patients who are allergic to gadolinium contrast agent
- Patients with contraindications to magnetic resonance imaging
- Patients with severe heart and lung diseases
- Patients who are not suitable for this study according to the researcher's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Guangjie Yang, PhD, +86 17853297979, ygj_2815@qq.com
About this study
It is an open label observation clinical trial, all participants are liver transplant patients. The investigators deem to make a better criteria for assessing liver fibrosis after liver transplantation. The point of the clinical trial is to evaluate the efficacy of multiparameter MRI in the diagnosis of liver fibrosis after liver transplantation.
Read the detailed description
We collected patients aged 18 to 85 who had undergone liver transplantation. At the same time, all patients underwent liver biopsy or ultrasonic transient elastography after MRI. People who were allergic to gadolinium contrast agent, serious cardiopulmonary disease and contraindications to MRI were excluded.
- Being tested
- Gadopentetate Dimeglumine Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadopentetate Dimeglumine InjectionDiagnostic test
Patients with liver fibrosis after liver transplantation receive multi-parameter magnetic resonance scanning, percutaneous liver biopsy (or FibroScan).
What is being measured
The primary outcome is the main question the study is designed to answer.
Mp-MRI in the Diagnosis of Liver Fibrosis After Liver Transplantation
Mp-MRI as a PET-CT biomarker to Liver Fibrosis after Liver Transplantation
Measured: 03.18.2022 to12.01.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start18 Mar 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Fibrosis After Liver TransplantationStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guangjie Yang, PhD, Study chair, The affiliated hostpital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292885
- Sponsor's protocol ID
- QYFYWZLL26786
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mp-MRI in the Diagnosis of Liver Fibrosis After Liver Transplantation
- ClinicalTrials.gov ID
- NCT05292885
- Acronym / sponsor ID
- QYFYWZLL26786
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 18 Mar 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 Mar 2022 (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.
It is an open label observation clinical trial, all participants are liver transplant patients. The investigators deem to make a better criteria for assessing liver fibrosis after liver transplantation. The point of the clinical trial is to evaluate the efficacy of multiparameter MRI in the diagnosis of liver fibrosis after liver transplantation.
Detailed description
We collected patients aged 18 to 85 who had undergone liver transplantation. At the same time, all patients underwent liver biopsy or ultrasonic transient elastography after MRI. People who were allergic to gadolinium contrast agent, serious cardiopulmonary disease and contraindications to MRI were excluded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with liver fibrosis after liver transplantation underwent percutaneous liver biopsy or FibroScan.
Key inclusion criteria (4 listed)
- Subjects aged 18 -85 years
- Patients after liver transplantation
- Patients who are going to undergo liver biopsy or ultrasonic transient elastography
- Patients voluntarily joined the study and signed informed consent
Key exclusion criteria (5 listed)
- Patients with tumor
- Patients who are allergic to gadolinium contrast agent
- Patients with contraindications to magnetic resonance imaging
- Patients with severe heart and lung diseases
- Patients who are not suitable for this study according to the researcher's judgment.
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 |
|---|---|---|
| Gadopentetate Dimeglumine InjectionPatients with liver fibrosis after liver transplantation receive multi-parameter magnetic resonance scanning, percutaneous liver biopsy (or FibroScan). | Diagnostic test | – |
Primary outcome
Mp-MRI in the Diagnosis of Liver Fibrosis After Liver Transplantation
Time frame: 03.18.2022 to12.01.2022
Mp-MRI as a PET-CT biomarker to Liver Fibrosis after Liver Transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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. This study is not recruiting at the moment.
Guangjie Yang, PhD study chair
The affiliated hostpital of Qingdao University
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 Liver Fibrosis After Liver Transplantation and Multiparameter Magnetic Resonance Imaging, run by The Affiliated Hospital of Qingdao University 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: status not confirmed, as of the sponsor's last update on 23 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangjie Yang, PhD (+86 053282913399, ygj_2815@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mp-MRI in the Diagnosis of Liver Fibrosis After Liver Transplantation (time frame: 03.18.2022 to12.01.2022). 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 23 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.