the Value of Multimodal Magnetic Resonance Imaging in the Diagnosis and Treatment Monitoring of Diabetic Kidney Disease
Overview
- Phase
- Not Applicable
- Intervention
- Magnetic Resonance Imaging
- Conditions
- Diabetic Kidney Disease
- Sponsor
- Shengjing Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Imaging Evaluation of Kidney
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
Brief 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.
Investigators
Yu Shi
Deputy director of department of radiology
Shengjing Hospital
Eligibility Criteria
Inclusion Criteria
- •Clinically diagnosed diabetic kidney disease (DKD)
- •Age 18-80 years
Exclusion Criteria
- •Malignant tumor, active infection, or life expectancy \<1 year
- •Pregnancy or lactation
- •MRE contraindications (metal implants, claustrophobia, severe arrhythmia) or poor image quality
- •eGFR \<15 mL/min/1.73m² or receiving renal replacement therapy
- •Other primary kidney diseases or systemic diseases affecting renal function
Arms & Interventions
DKD Patients
Participants with diagnosed Diabetic Kidney Disease (DKD) will undergo the same MRI protocol as the Healthy Volunteers, including Blood Oxygen Level Dependence (BOLD), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1\&T2-mapping imaging, and Magnetic Resonance Elastography (MRE). In addition to the imaging, these participants will have their blood creatinine, cystatin C, blood pressure, and urine albumin-to-creatinine ratio (UACR) measured within 3 days before and after the MRE. A renal biopsy will be performed in a subset of these participants as part of their clinical assessment to evaluate the extent of kidney damage.
Intervention: Magnetic Resonance Imaging
Healthy Volunteers
Age-matched healthy individuals with no known kidney disease will be recruited. They will undergo the same MRI protocols as the DKD group, including Blood Oxygen Level Dependence (BOLD), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1\&T2-mapping imaging and Magnetic Resonance Elastography (MRE), to establish baseline viscoelasticity parameters for comparison with the Diabetics.
Intervention: Magnetic Resonance Imaging
Outcomes
Primary Outcomes
Imaging Evaluation of Kidney
Time Frame: Baseline to 6 months
To evaluate the ability of Multimodal Magnetic Resonance Imaging to identify and quantify the extent of of kidney damage. Regions of interest (ROIs) were placed manually in the renal cortex and medulla, avoiding renal hilar vessels and areas of obvious artifacts.
Rate of Decline in Estimated Glomerular Filtration Rate (eGFR Slope)
Time Frame: From enrollment to the end of follow-up at 24 months
The primary outcome is the rate of change in estimated glomerular filtration rate (eGFR), calculated using serum creatinine and cystatin C, expressed as eGFR slope (mL/min/1.73m² per year). eGFR will be measured at baseline and 6 months to assess kidney function decline. Baseline multimodal MRI parameters (BOLD, IVIM, ASL, T1/T2 mapping, MRE) will be evaluated for their ability to predict subsequent eGFR decline.