Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function After Liver Transplantation

NCT ID: NCT06994429

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2030-09-30

Brief 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 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.

Conditions

Liver Transplantation; MRI; Graft Function

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Patients who have undergone liver transplantation.

2. Patients who are scheduled for MR imaging post-transplant.

3. Voluntary participation with signed informed consent.

Exclusion Criteria

1. Patients with contraindications for MRI, such as pacemakers, unknown metallic implants, or neurostimulators.

2. Patients with claustrophobia or inability to tolerate the required breath-holds for MRI.

3. Patients who cannot comply with the study requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhen Li

OTHER

Sponsor Role: lead

Responsible Party

Zhen Li

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tongji hospital, NO.1095 jiefang avenue

Wuhan, Hubei, China

Countries

China

Other Identifiers

TJ-IRB202411026

Identifier Type: -

Identifier Source: org_study_id