To Explore the Value of Magnetic Resonance Imaging in Noninvasive Quantitative Evaluation of Graft Function After Simultaneous Pancreas-kidney Transplantation

NCT07001917 | Enrolling By Invitation

• 1 other identifier: TJ-IRB202409057
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic kidney joint transplantation (SPK) has become the standard treatment for patients with diabetes complicated by end-stage renal disease. By simultaneously transplanting the pancreas and kidney, SPK can restore the patient\'s insulin secretion and kidney function after surgery, thereby significantly improving the patient\'s quality of life and extending life expectancy. However, the high incidence of postoperative complications, especially organ dysfunction, remains a major challenge. Complications of organ dysfunction include thrombosis of the pancreatic graft, acute rejection, graft pancreatitis, and acute tubular necrosis of the renal graft. Early diagnosis and monitoring of these complications are crucial for improving patient prognosis and extending the life of the transplanted organs. Although some methods are currently used in clinical practice to assess graft function, such as estimated glomerular filtration rate (eGFR) and Gates method of renal dynamic imaging, these methods still have significant limitations. For example, traditional biochemical markers for predicting kidney function are affected by many irrelevant factors and lack accuracy. While the Gates method is widely used, its long examination process, high cost, and radiation exposure limit its feasibility in routine postoperative application. In addition, although tissue biopsy is considered the gold standard for assessing renal pathology, its invasiveness and potential complications limit its application. In view of the shortcomings of traditional methods, there is an urgent need for a non-invasive, dynamic, and accurate detection method for the early diagnosis of post-SPK organ dysfunction. Magnetic resonance imaging (MRI) has shown great potential in the assessment of transplanted organ function due to its non-invasiveness, high soft tissue resolution, and multi-parametric analysis capabilities. MRI can not only display the anatomical structure of the transplanted organs in detail but also dynamically monitor the blood perfusion and tissue oxygenation levels of the transplanted organs through advanced imaging techniques, such as arterial spin labeling (ASL) and blood oxygenation level-dependent (BOLD) imaging. The application of these new technologies helps to discover complications early and provides important diagnostic information, thereby improving patient prognosis. Therefore, this study aims to explore the application of MRI in the functional assessment of transplanted organs after SPK, especially its potential in the early diagnosis and monitoring of organ dysfunction. Through this study, we hope to provide a new non-invasive diagnostic method for the early discovery of post-SPK complications, thereby improving the long-term prognosis of patients and filling the gap in current clinical practice.

Conditions

Simultaneous Pancreas-Kidney Transplantation

Keywords

Simultaneous Pancreas-Kidney Transplantation; MRI

Outcome Measures

Primary Outcomes (1)

• Diffusion sequence measures cell parameters

  The patient reaches CKD stage 5 and the glomerular filtration rate is less than 15 ml/min

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Study Arms (2)

The patient reaches CKD stage 5 and the glomerular filtration rate is less than 15 ml/min

Perform multimodal MRI scanning

Control group

Get an MRI scan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone simultaneous pancreas-kidney transplantation

You may qualify if:

• Patients who have undergone combined pancreas-kidney transplantation and are prescribed an MRI examination
• Age/Gender: No restrictions
• Patients who voluntarily participate in the clinical trial and sign a written informed consent form

You may not qualify if:

• Patients with a pacemaker, unknown material implants, metal implants, neurostimulators, or claustrophobia 2.Patients who cannot tolerate sufficient breath-holding for a complete MRI examination

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: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): September 17, 2030
• Study Completion (Estimated): December 12, 2030
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)