To Explore the Application Value of Magnetic Resonance Imaging in Noninvasive Quantitative Evaluation of Graft Function and Systemic Metabolism After Renal Transplantation

NCT ID: NCT07145944

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2031-12-12

Brief Summary

At present, renal biopsy is the gold standard for evaluating the pathology of renal transplants, but it is invasive and has the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias and lacks reliable and comprehensive detection results. Therefore, it is an urgent problem to develop a non-invasive dynamic detection method for renal insufficiency and transplanted kidney.

With the continuous development and updating of technology, imaging provides a new way for non-invasive evaluation of renal allograft pathology including rejection reaction, acute renal allograft injury, viral infection, etc. MRI technology has developed the diagnosis of renal allograft rejection, fibrosis and other renal allograft dysfunction from macroscopic simple biomorphological changes to microscopic complex pathophysiological changes due to its high resolution of soft tissue and its ability to perform multi-parameter analysis.

In recent years, under the background of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the evaluation of transplanted kidney images. They can extract and learn features in images with high throughput, make greater use of information that cannot be recognized by human eyes in medical images, and realize disease diagnosis, prognosis evaluation, and curative effect prediction by establishing models. However, most of the current research is in the preliminary stage. There are few evaluation studies on kidney transplantation. It is believed that with the continuous improvement of algorithms and optimization of models, radiomics and machine learning will make great progress, which will promote the development of individualized and precise medicine for patients with renal insufficiency to a certain extent.

Detailed Description

At present, renal biopsy is the gold standard for evaluating the pathology of renal transplants, but it is invasive and has the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias and lacks reliable and comprehensive detection results. Therefore, it is an urgent problem to develop a non-invasive dynamic detection method for renal insufficiency and transplanted kidney.

With the continuous development and updating of technology, imaging provides a new way for non-invasive evaluation of renal allograft pathology including rejection reaction, acute renal allograft injury, viral infection, etc. MRI technology has developed the diagnosis of renal allograft rejection, fibrosis and other renal allograft dysfunction from macroscopic simple biomorphological changes to microscopic complex pathophysiological changes due to its high resolution of soft tissue and its ability to perform multi-parameter analysis.

In recent years, under the background of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the evaluation of transplanted kidney images. They can extract and learn features in images with high throughput, make greater use of information that cannot be recognized by human eyes in medical images, and realize disease diagnosis, prognosis evaluation, and curative effect prediction by establishing models. However, most of the current research is in the preliminary stage. There are few evaluation studies on kidney transplantation. It is believed that with the continuous improvement of algorithms and optimization of models, radiomics and machine learning will make great progress, which will promote the development of individualized and precise medicine for patients with renal insufficiency to a certain extent.

Conditions

Kidney Transplant Failure and Rejection; Transplantation, Kidney; Kidney Transplant Dysfunction

Study Design

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

Study Groups

renal allograft patients

renal allograft patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• (1) Patients with MR examination after kidney transplantation;

(2) Age/gender: unlimited;

(3) Patients who voluntarily participate in clinical trials and sign written subject informed consent

Exclusion Criteria

• (1) Patients with pacemakers, unknown materials, metal implants, neurostimulators, claustrophobia, etc.

(2) Patients who cannot tolerate adequate breath-holding for adequate MR examination;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhen Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhen Professor Li, PHD,MD

Role: CONTACT

zhenli@hust.edu.cn

02783663543

Other Identifiers

TJ-IRB202411041

Identifier Type: -

Identifier Source: org_study_id