Multifrequency MRE in Evaluation of Chronic Kidney Diseases
Multifrequency Renal MR Elastography in Evaluation of Chronic Kidney Diseases: Can Shear Stiffness Evaluate Renal Fibrosis in GFR-normal Patients?
1 other identifier
observational
200
1 country
1
Brief Summary
Chronic Kidney Disease (CKD) is a major public health issue, leading to high mortality and the necessity for renal replacement therapy. Kidney fibrosis, resulting from chronic damage to kidney tissue, significantly determines CKD outcomes. Kidney biopsy, the gold standard for assessing fibrosis, is invasive and limited in its ability to reflect the heterogeneous nature of fibrosis. Consequently, there is growing interest in noninvasive methods, particularly Magnetic Resonance Elastography (MRE). MRE, which evaluates tissue stiffness, has shown potential for assessing kidney fibrosis. This study aims to use multifrequency MRE to assess renal fibrosis, focusing particularly on the early stages of CKD, to enhance understanding of its progression and relationship to clinical outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2022
CompletedFirst Submitted
Initial submission to the registry
January 1, 2024
CompletedFirst Posted
Study publicly available on registry
January 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 8, 2027
February 10, 2026
February 1, 2026
4.7 years
January 1, 2024
February 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annual rate of eGFR decline
Serum biochemical markers, including eGFR, will be assessed, and a multi-parametric MRI scan (including MRE, IVIM, ASL, BOLD, and T1 mapping) will be performed within 7 days to collect baseline parameters. Following this, eGFR will be monitored every 3 to 6 months for a minimum of 2 years to calculate the annual rate of eGFR decline
24 months
Study Arms (2)
CKD Patients
Participants with diagnosed Chronic Kidney Disease will undergo the same MRI protocol as the Healthy Volunteers, including T1-weighted imaging, T2-weighted imaging, MR Elastography (MRE), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1 mapping, Blood Oxygen Level Dependent (BOLD), and Diffusion Weighted Imaging (DWI). The renal MRI will be performed within 7 days of the renal biopsy. In addition to the imaging, these participants will have their blood creatinine, cystatin C, blood pressure etc., measured.
Healthy Volunteers
Age-matched healthy individuals with no known kidney disease will be recruited. They will undergo the same MRI protocols as the CKD patient group, to establish baseline viscoelasticity parameters for comparison with the CKD patients.
Interventions
Both CKD patients and healthy volunteers will undergo a comprehensive MRI protocol, including T1-weighted imaging, T2-weighted imaging, Magnetic Resonance Elastography (MRE), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1 mapping, Blood Oxygen Level Dependent (BOLD), and Diffusion-Weighted Imaging (DWI) to evaluate liver and renal characteristics. For CKD patients, renal MRI will be performed within 7 days of the renal biopsy . Additionally, blood tests for creatinine and cystatin C, along with blood pressure measurements, will be collected.
Eligibility Criteria
Adult patients with CKD stages 1-5 and healthy age-matched adults as controls
You may qualify if:
- (1) adults with CKD defined according to the 2024 KDIGO guidelines, with either elevated SCr or abnormal proteinuria ; and (2) renal MRI was performed within 7 days of the renal biopsy.
You may not qualify if:
- (1) genitourinary malignancy, polycystic kidney disease, renal transplantation, or acute renal failure; (2) contraindications for MRI examination; (3) poor image quality; (4) kidney deformity or severe hydronephrosis on MRI; and (5) poorly defined corticomedullary demarcation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Related Publications (2)
Han JH, Ahn JH, Kim JS. Magnetic resonance elastography for evaluation of renal parenchyma in chronic kidney disease: a pilot study. Radiol Med. 2020 Dec;125(12):1209-1215. doi: 10.1007/s11547-020-01210-1. Epub 2020 May 4.
PMID: 32367323RESULTGrossmann M, Tzschatzsch H, Lang ST, Guo J, Bruns A, Durr M, Hoyer BF, Grittner U, Lerchbaumer M, Nguyen Trong M, Schultz M, Hamm B, Braun J, Sack I, Marticorena Garcia SR. US Time-Harmonic Elastography for the Early Detection of Glomerulonephritis. Radiology. 2019 Sep;292(3):676-684. doi: 10.1148/radiol.2019182574. Epub 2019 Jul 9.
PMID: 31287390RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yu shi, MD
Shengjing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director of department of radology
Study Record Dates
First Submitted
January 1, 2024
First Posted
January 11, 2024
Study Start
October 10, 2022
Primary Completion (Estimated)
June 8, 2027
Study Completion (Estimated)
June 8, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share