NCT06452862

Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease

the Value of Multimodal Magnetic Resonance Imaging in the Diagnosis and Treatment Monitoring of Diabetic Kidney Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to investigate the value of noninvasive evaluation of multimodal magnetic resonance imaging in diagnosis and treatment of diabetic kidney disease (DKD). We aim to explore the feasibility of multimodal magnetic resonance imaging in the staging diagnosis of DKD, and establish a non-invasive method for evaluating the progression of DKD disease by combining imaging and biochemical indicators. Multimodal magnetic resonance examinations will be performed on diabetic patients with different stages as well as regular follow-up during treatment, in order to investigate the relationship between imaging findings and pathophysiological changes of the kidneys.

Detailed description

At present, the clinical diagnosis of diabetic kidney disease (DKD) relies mainly on the detection of urine microalbumin，which is influenced by many other factors. Renal biopsy is another modality to detect DKD, but it cannot be widely used in clinical practice because of its invasiveness. Thus, a reproducible and reliable noninvasive method is needed for more accurate diagnosis. Multimodal magnetic resonance imaging, which including but not limited to magnetic resonance elastography (MRE), blood oxygen level-dependent magnetic resonance imaging (BOLD-MRI), arterial spin labeling (ASL), incoherent motion diffusion-weighted imaging (IVIM-DWI), T1mapping and T2mapping, is able to provide valuable information about subtle structural and functional changes, and has shown promising potential in the diagnosis, classification and prediction of pathological and molecular features. In this clinical trial, multimodal magnetic resonance examinations will be performed on diabetic patients with different stages as well as regular follow-up during treatment, in order to investigate the relationship between imaging findings and pathophysiological changes of the kidneys. We aim to explore the feasibility of multimodal magnetic resonance imaging in the staging diagnosis of DKD and establish a non-invasive method for evaluating the progression of DKD disease by combining imaging and biochemical indicators, in order to provide reference for clinical medication. This research could be helpful for better understanding and management of DKD, and pave the way for more accurate diagnosis, improved clinical decision-making, personalized treatment approaches for DKD patients.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Magnetic Resonance Imaging	Both Diabetic Kidney Disease (DKD) patients and Healthy Volunteers will undergo MRI protocols including Blood Oxygen Level Dependence (BOLD), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1\&T2-mapping imaging and Magnetic Resonance Elastography (MRE). For Diabetics, blood tests for creatinine and cystatin C, urine test for albumin-to-creatinine ratio (UACR), along with blood pressure measurements, will be taken within a three-day window surrounding the MRE test. Additionally, Diabetics will undergo a renal biopsy to assess the extent of kidney damage.

Timeline

• Start date: 2024-06-06
• Primary completion: 2027-06-06
• Completion: 2028-06-06
• First posted: 2024-06-11
• Last updated: 2026-04-13

Locations

1 site across 1 country: China