Non-contrast MRI tracking of kidney transplant function using donor baselines
Official title: A Mixed Cohort, Multicentre Exploratory Study of Non-invasive Quantitative Assessment of Renal Graft Function With Non-contrast Functional Magnetic Resonance Imaging
Run by Tongji Hospital · NCT07333495 · Data updated 2026-11-12
This study will test whether non-contrast MRI scans can track kidney transplant health over time by using donor scans as personalized baselines and by applying the technique to recipients without donor data, for adults who have had or will receive a kidney transplant.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 3 sites (Shiyan, Hubei and 2 other locations) |
| Status | Recruiting |
| Started | December 4, 2025 |
| Main results expected | December 31, 2032 |
| Study ends | December 31, 2033 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT07333495 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) who are living kidney donors and their matched recipients, or transplant recipients (especially from deceased donors) able to undergo MRI and provide informed consent are ideal candidates.
✕Probably not a fit
Patients with MRI contraindications (e.g., incompatible implants, severe claustrophobia), those unable to perform required breath-holds, pregnant people, or those with clinical conditions that preclude reliable participation are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, multicenter hybrid cohort study uses a standardized non-contrast functional MRI protocol (including DWI, ASL, BOLD, and MT sequences) to quantify renal perfusion, oxygenation, diffusion, and microstructure. The study enrolls paired donor-recipient sets where donors undergo pre-transplant MRI to create individualized baselines, plus an independent recipient cohort (primarily deceased-donor transplants) to validate MRI metrics without donor baselines. MRI measures will be integrated with body composition, metabolic profiles, and routine clinical and laboratory data to build models for early detection, treatment monitoring, and prognosis of graft function. Imaging and clinical data will be collected across multiple centers in China and analyzed for reproducibility and diagnostic performance.
Why it matters
Potential benefit: If successful, this approach could enable earlier, non-invasive detection of graft dysfunction and reduce reliance on invasive biopsies.
How similar studies have gone: Pilot and single-center studies using ASL, BOLD, and DWI for renal grafts have shown promising signals, but large multicenter validation of a combined non-contrast protocol remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult participants (age ≥ 18 years). For the Paired Donor-Recipient Cohort: Donor: Scheduled for living kidney donation, OR is a deceased organ donor who can undergo a pre-transplant MRI. Recipient: Recipient of a kidney transplant or simultaneous pancreas-kidney transplant from the paired donor. For the Independent Recipient Cohort: Recipient: Recipient of a kidney transplant from a deceased donor for whom donor baseline data is unavailable. Able to provide informed consent. Exclusion Criteria: Any contraindication to MRI (e.g., cardiac pacemaker, non-MRI compatible metallic implants, neurostimulators, severe claustrophobia). Inability to tolerate the breath-holding required for MRI acquisition. Pregnancy. Any clinical condition that, in the investigator's judgment, would severely compromise study participation or data integrity (e.g., uncontrolled severe infection, active major psychiatric illness).
Where it's running
-
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting -
Sinopharm Dongfeng General Hospital, Dongfeng Motor Corporation and Hubei University of Medicine.
Shiyan, Hubei, China Not yet recruiting -
Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Shanxi Medical University
Taiyuan, Shanxi, China Not yet recruiting
Study contacts
- Study coordinator: Zhen Professor Li, PHD,MD
- Email: zhenli@hust.edu.cn
- Phone: 02783663543
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.