Actively Recruiting
A Mixed Cohort, Multicentre Exploratory Study of Non-invasive Quantitative Assessment of Renal Graft Function With Non-contrast Functional Magnetic Resonance Imaging
Led by Tongji Hospital · Updated on 2026-01-12
1000
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
N
National Natural Science Foundation of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new, non-invasive method to monitor kidney function after transplantation using advanced non-contrast Magnetic Resonance Imaging (MRI). This study aims to create individualized baselines for transplanted kidneys by scanning donors before donation, allowing earlier detection of kidney problems compared to current blood tests or biopsies. It includes both donor-recipient pairs and recipients without donor data, primarily from deceased donors, to evaluate MRI's ability to track kidney health over time. Participants are divided into two main groups: one where donors undergo pre-transplant MRI to establish a personalized baseline for their kidney before transplant, and recipients are followed post-transplant to compare function against this baseline; the other group includes recipients without donor MRI data to validate MRI's standalone monitoring ability. The study also assesses body composition and metabolic health to better understand their impact on transplant kidney function. During the study, participants will undergo scheduled non-contrast MRI scans alongside clinical, laboratory, and body composition assessments. Data such as serum creatinine, eGFR, and biopsy results when available will be collected to correlate with MRI findings. The main outcome is the diagnostic accuracy of MRI for detecting transplant kidney rejection and dysfunction over up to five years. Approximately 1000 participants will be enrolled to provide robust data for developing a precise, individualized monitoring tool for kidney transplant patients.
CONDITIONS
Brief Title
A Mixed Cohort, Multicentre Exploratory Study of Non-invasive Quantitative Assessment of Renal Graft Function With Non-contrast Functional Magnetic Resonance Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants aged 18 years or older
- Donors scheduled for living kidney donation or deceased donors who can undergo pre-transplant MRI
- Recipients of kidney or simultaneous pancreas-kidney transplants from paired donors
- Recipients of kidney transplants from deceased donors without donor baseline data
- Ability to provide informed consent
You will not qualify if you...
- Any contraindications to MRI such as cardiac pacemakers, non-MRI compatible metallic implants, neurostimulators, or severe claustrophobia
- Inability to tolerate breath-holding required for MRI scans
- Pregnancy
- Any clinical condition judged by investigators to severely compromise study participation or data integrity, such as uncontrolled severe infection or active major psychiatric illness
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At transplantation and scheduled follow-ups up to 5 years
Participants undergo non-contrast functional MRI scans and clinical assessments to evaluate kidney graft function. For the paired donor-recipient cohort, donors have a pre-transplant MRI to establish an individualized functional baseline.
MRI scans and clinical data collection at baseline and at Years 1, 2, 3, 4, and 5 post-transplant
Duration - Up to 5 years post-transplant
Participants are monitored over time to assess changes in graft function using MRI parameters, clinical laboratory results, and body composition analysis to detect early graft dysfunction and evaluate long-term outcomes.
Follow-up visits aligned with MRI assessments at Years 1 through 5 post-transplant
Trial Site Locations
Total: 3 locations
1
Sinopharm Dongfeng General Hospital, Dongfeng Motor Corporation and Hubei University of Medicine.
Shiyan, Hubei, China
Not Yet Recruiting
2
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
3
Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Shanxi Medical University
Taiyuan, Shanxi, China
Not Yet Recruiting
Research Team
Z
Zhen Professor Li, PHD,MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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