Liver TransplantationNCT06994429
Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function After Liver Transplantation
An observational study of Liver Transplantation and MRI, run by Zhen Li at 1 site in China.
Trial summary
Title: Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation Purpose of the Study: This study aims to investigate the value of new imaging technologies in assessing early graft function in patients who have… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation, MRI, Graft Function
- What is being tested?
- MRI Techniques for Graft Function Assessment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to Sep 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes post-liver transplant patients at Tongji Hospital who are eligible for MRI scans and meet the inclusion and exclusion criteria. Participants are of all ages and genders, ensuring a broad demographic representation.
Who may be able to join
- Patients who have undergone liver transplantation.
- Patients who are scheduled for MR imaging post-transplant.
- Voluntary participation with signed informed consent.
Who cannot join
- Patients with contraindications for MRI, such as pacemakers, unknown metallic implants, or neurostimulators.
- Patients with claustrophobia or inability to tolerate the required breath-holds for MRI.
- Patients who cannot comply with the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Title: Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation
Purpose of the Study:
Read more
This study aims to investigate the value of new imaging technologies in assessing early graft function in patients who have undergone liver transplantation. By analyzing clinical, imaging, laboratory, and pathological data from liver transplant patients, the study seeks to establish a non-invasive method for diagnosing, evaluating treatment efficacy, and predicting outcomes related to graft function.
Background:
Liver transplantation is a critical treatment for end-stage liver disease and acute liver failure. While it significantly improves patients' quality of life and survival rates, complications such as graft dysfunction can occur post-surgery. Traditional methods for assessing graft function, including liver function tests, imaging studies (like ultrasound and CT), and biopsy, have limitations in sensitivity and specificity. Therefore, there is a need for safer, non-invasive techniques that can provide a comprehensive assessment of graft function.
Study Design:
Type: Prospective study Participants: 1000 liver transplant patients who meet specific inclusion criteria, such as undergoing MR imaging post-transplant.
Exclusion Criteria: Patients with contraindications for MRI, such as implanted devices or claustrophobia.
Methods:
Participants will undergo MRI scans using advanced techniques like diffusion-weighted imaging (DWI) and dynamic contrast-enhanced MRI (DCE-MRI) to evaluate graft function. Clinical and laboratory data will also be collected for comprehensive analysis.
Potential Benefits:
This study aims to enhance the early detection of graft dysfunction, allowing for timely interventions that could improve patient outcomes and prolong graft survival.
Risks and Safeguards:
While there is a risk of privacy breaches regarding patient data, all information will be handled confidentially and used solely for research purposes. Patient identities will be protected throughout the study.
Conclusion:
The findings from this study could lead to improved non-invasive assessment methods for liver transplant patients, ultimately enhancing clinical decision-making and patient care.
Read the detailed description
Title: Exploration of New Magnetic Resonance Imaging Technologies for Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation
Principal Investigator: Professor Li Zhen
Research Institution: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Objective:
The study aims to explore the value of new imaging technologies in assessing the early postoperative graft function in liver transplant patients. It seeks to establish relationships between imaging parameters, body composition, metabolic diseases, and graft function, with the goal of guiding clinical treatment and improving survival rates and quality of life for liver transplant patients.
Study Design:
Type: Prospective Sample Size: 1000 cases, calculated based on multivariate analysis requirements and considering a dropout rate of around 20%.
Eligibility Criteria:
Inclusion: Patients who have undergone liver transplantation and are scheduled for MR examinations.
Exclusion: Patients with contraindications for MRI such as pacemakers, unknown metallic implants, neurostimulators, claustrophobia, or those who cannot hold their breath for the duration of the MR scan.
Withdrawal Criteria:
Serious adverse events Poor compliance Patient's request to withdraw Investigator's decision that continuation of the study is not in the patient's best interest
Study Process:
Imaging Data Collection: Patients meeting the criteria will be informed and consented. They will undergo MR scans after fasting for 8 hours and hydrating for 4 hours. Imaging data will be collected and documented.
Imaging Data Processing: DICOM format images will be copied from the PACS system and analyzed using imaging processing software to record relevant parameters.
Clinical Data Collection: Clinical and laboratory data will be collected through the RIS system at Tongji Hospital, including liver function tests, blood tests, and pathological data. Patient histories and treatment information will also be documented.
Risks and Precautions:
Risks: Potential of patient privacy due to the use of imaging and electronic medical records.
Precautions: All data used in the study will be anonymized to protect patient identity and will not be used for commercial purposes.
Data Collection and Statistical Analysis:
Data will be analyzed using statistical software like SPSS after collection and organization of clinical, laboratory, and outcome data.
- Conditions
- Liver Transplantation, MRI, Graft Function
- Being tested
- MRI Techniques for Graft Function Assessment
- Keywords
- Graft Function, Liver Transplantation, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Techniques for Graft Function AssessmentDiagnostic test
### Intervention Description
The intervention in this study is the use of advanced MRI techniques for assessing liver transplant graft function. It includes:
- Diffusion Weighted Imaging (DWI): To evaluate tissue integrity and detect early graft dysfunction.
- Dynamic Contrast-Enhanced MRI (DCE-MRI): To assess vascular complications and blood flow in the graft.
- Blood Oxygenation Level-Dependent (BOLD) MRI: To monitor oxygenation levels, indicative of graft health.
These MRI methods provide a non-invasive, comprehensive assessment of liver graft function, distinguishing this intervention from traditional invasive methods like biopsy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation
This study focuses on employing advanced MRI techniques to non-invasively evaluate the function of liver transplant grafts, distinguishing it from traditional methods by offering a comprehensive, less invasive approach to post-transplant care.
Measured: The study is a prospective analysis of 1000 liver transplant patients to assess graft function using MRI. The study is expected to last up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jun 2024
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhen Li, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994429
- Sponsor's protocol ID
- TJ-IRB202411026
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 29 May 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function After Liver Transplantation
- ClinicalTrials.gov ID
- NCT06994429
- Acronym / sponsor ID
- TJ-IRB202411026
- Conditions
- Liver Transplantation, MRI, Graft Function
- Keywords
- Graft Function, Liver Transplantation, MRI
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhen LiUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 29 May 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.
Title: Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation
Purpose of the Study:
This study aims to investigate the value of new imaging technologies in assessing early graft function in patients who have undergone liver transplantation. By analyzing clinical, imaging, laboratory, and pathological data from liver transplant patients, the study seeks to establish a non-invasive method for diagnosing, evaluating treatment efficacy, and predicting outcomes related to graft function.
Background:
Liver transplantation is a critical treatment for end-stage liver disease and acute liver failure. While it significantly improves patients' quality of life and survival rates, complications such as graft dysfunction can occur post-surgery. Traditional methods for assessing graft function, including liver function tests, imaging studies (like ultrasound and CT), and biopsy, have limitations in sensitivity and specificity. Therefore, there is a need for safer, non-invasive techniques that can provide a comprehensive assessment of graft function.
Study Design:
Type: Prospective study Participants: 1000 liver transplant patients who meet specific inclusion criteria, such as undergoing MR imaging post-transplant.
Exclusion Criteria: Patients with contraindications for MRI, such as implanted devices or claustrophobia.
Methods:
Participants will undergo MRI scans using advanced techniques like diffusion-weighted imaging (DWI) and dynamic contrast-enhanced MRI (DCE-MRI) to evaluate graft function. Clinical and laboratory data will also be collected for comprehensive analysis.
Potential Benefits:
This study aims to enhance the early detection of graft dysfunction, allowing for timely interventions that could improve patient outcomes and prolong graft survival.
Risks and Safeguards:
While there is a risk of privacy breaches regarding patient data, all information will be handled confidentially and used solely for research purposes. Patient identities will be protected throughout the study.
Conclusion:
The findings from this study could lead to improved non-invasive assessment methods for liver transplant patients, ultimately enhancing clinical decision-making and patient care.
Detailed description
Title: Exploration of New Magnetic Resonance Imaging Technologies for Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation
Principal Investigator: Professor Li Zhen
Research Institution: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Objective:
The study aims to explore the value of new imaging technologies in assessing the early postoperative graft function in liver transplant patients. It seeks to establish relationships between imaging parameters, body composition, metabolic diseases, and graft function, with the goal of guiding clinical treatment and improving survival rates and quality of life for liver transplant patients.
Study Design:
Type: Prospective Sample Size: 1000 cases, calculated based on multivariate analysis requirements and considering a dropout rate of around 20%.
Eligibility Criteria:
Inclusion: Patients who have undergone liver transplantation and are scheduled for MR examinations.
Exclusion: Patients with contraindications for MRI such as pacemakers, unknown metallic implants, neurostimulators, claustrophobia, or those who cannot hold their breath for the duration of the MR scan.
Withdrawal Criteria:
Serious adverse events Poor compliance Patient's request to withdraw Investigator's decision that continuation of the study is not in the patient's best interest
Study Process:
Imaging Data Collection: Patients meeting the criteria will be informed and consented. They will undergo MR scans after fasting for 8 hours and hydrating for 4 hours. Imaging data will be collected and documented.
Imaging Data Processing: DICOM format images will be copied from the PACS system and analyzed using imaging processing software to record relevant parameters.
Clinical Data Collection: Clinical and laboratory data will be collected through the RIS system at Tongji Hospital, including liver function tests, blood tests, and pathological data. Patient histories and treatment information will also be documented.
Risks and Precautions:
Risks: Potential of patient privacy due to the use of imaging and electronic medical records.
Precautions: All data used in the study will be anonymized to protect patient identity and will not be used for commercial purposes.
Data Collection and Statistical Analysis:
Data will be analyzed using statistical software like SPSS after collection and organization of clinical, laboratory, and outcome data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes post-liver transplant patients at Tongji Hospital who are eligible for MRI scans and meet the inclusion and exclusion criteria. Participants are of all ages and genders, ensuring a broad demographic representation.
Key inclusion criteria (3 listed)
- Patients who have undergone liver transplantation.
- Patients who are scheduled for MR imaging post-transplant.
- Voluntary participation with signed informed consent.
Key exclusion criteria (3 listed)
- Patients with contraindications for MRI, such as pacemakers, unknown metallic implants, or neurostimulators.
- Patients with claustrophobia or inability to tolerate the required breath-holds for MRI.
- Patients who cannot comply with the study requirements.
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 |
|---|---|---|
| MRI Techniques for Graft Function Assessment### Intervention Description The intervention in this study is the use of advanced MRI techniques for assessing liver transplant graft function. It includes: * Diffusion Weighted Imaging (DWI): To evaluate tissue integrity and detect early graft dysfunction. * Dynamic Contrast-Enhanced MRI (DCE-MRI): To assess vascular complications and blood flow in the graft. * Blood Oxygenation Level-Dependent (BOLD) MRI: To monitor oxygenation levels, indicative of graft health. These MRI methods provide a non-invasive, comprehensive assessment of liver graft function, distinguishing this intervention from traditional invasive methods like biopsy. | Diagnostic test | – |
Primary outcome
Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation
Time frame: The study is a prospective analysis of 1000 liver transplant patients to assess graft function using MRI. The study is expected to last up to 5 years.
This study focuses on employing advanced MRI techniques to non-invasively evaluate the function of liver transplant grafts, distinguishing it from traditional methods by offering a comprehensive, less invasive approach to post-transplant care.
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 29 May 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transplantation and MRI, run by Zhen Li 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 29 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation (time frame: The study is a prospective analysis of 1000 liver transplant patients to assess graft function using MRI. The study is expected to last up to 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 29 May 2025.