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

NCT06994429 | Enrolling By Invitation

• 1 other identifier: TJ-IRB202411026
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; MRI; Graft Function

Keywords

Graft Function; Liver Transplantation; MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Interventions

MRI Techniques for Graft Function Assessment DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients who have undergone liver transplantation.
• Patients who are scheduled for MR imaging post-transplant.
• Voluntary participation with signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhen Li: lead

Study Sites (1)

Tongji hospital, NO.1095 jiefang avenue

Wuhan, Hubei, 430074, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

CN (1)