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临床试验/NCT06202235
NCT06202235
招募中
不适用

Multifrequency Renal MR Elastography in Evaluation of Chronic Kidney Diseases: Can Shear Stiffness Evaluate Renal Fibrosis in GFR-normal Patients?

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 200 人2022年10月10日

概览

阶段
不适用
干预措施
Magnetic Resonance Imaging
疾病 / 适应症
Chronic Kidney Disease (CKD)
发起方
Shengjing Hospital
入组人数
200
试验地点
1
主要终点
Annual rate of eGFR decline
状态
招募中
最后更新
2个月前

概览

简要总结

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.

详细描述

Chronic Kidney Disease (CKD) is a significant public health concern, impacting approximately 10% of the global population. Annually, millions face mortality or require renal replacement therapy due to CKD progression. Kidney fibrosis, a result of chronic parenchymal damage from various glomerular and tubulointerstitial insults, is a primary determinant of outcomes. Accurately assessing the extent and severity of fibrosis is vital for diagnosis and treatment. However, Glomerular Filtration Rate (GFR) may not diminish despite the presence of renal fibrosis, often until extensive damage occurs, owing to the kidney's compensatory abilities. Additionally, GFR reductions may not solely indicate chronic damage or parenchymal fibrosis. GFR estimates using serum markers offer only rough approximations of kidney fibrosis and can be misleading. The gold standard for assessing kidney fibrosis is a kidney biopsy. However, biopsies are invasive, with potential complications and sampling errors, as they assess less than 1% of the kidney parenchyma. Given the heterogeneous and patchy nature of fibrosis within kidneys, the efficacy of biopsies is further questioned. Serial biopsies to track fibrosis progression are also impractical. The need for noninvasive, accurate fibrosis assessment has led to research into various imaging techniques. Emerging functional MRI sequences, such as Intravoxel Incoherent Motion (IVIM) and Arterial Spin Labeling (ASL) for perfusion, Blood Oxygen Level Dependent (BOLD) for oxygenation, and T1 mapping for tissue characterization, offer multidimensional insights into renal pathology. Among these, Magnetic Resonance Elastography (MRE) appears particularly promising for directly assessing tissue mechanical properties. MRE, combining MRI with acoustic wave assessment, quantitatively determines tissue viscoelastic properties in response to external mechanical vibration. Initially developed for liver fibrosis assessment, kidney studies have shown that MRE-determined stiffness mildly negatively correlates with CKD stages and positively with fibrosis in renal allografts and diabetic kidneys. While kidney stiffness increases with fibrosis in renal allografts, it decreases with GFR in diabetic nephropathy. In CKD progression, marked by increased fibrosis and decreased GFR, these opposing effects on renal stiffness could limit MRE's applicability in CKD patients. We hypothesize that in early-stage CKD, when GFR is normal or slightly elevated, MRE could effectively determine renal fibrosis severity. To date, no study has specifically explored renal fibrosis and stiffness correlation in early-stage CKD. Therefore, this study aims to evaluate renal fibrosis using multifrequency 3D-MRE-derived stiffness as a surrogate marker. This involves detecting renal fibrosis prior to CKD changes, distinguishing renal fibrosis from CKD stages, and comparing renal stiffness with clinicopathological correlates in CKD patients. Additionally, we will briefly explore the complementary value of MRE alongside other functional MRI metrics (IVIM, ASL, BOLD, T1 mapping) and investigate their potential efficacy in predicting the prognosis of CKD progression.

注册库
clinicaltrials.gov
开始日期
2022年10月10日
结束日期
2027年6月8日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Yu Shi

Deputy director of department of radology

Shengjing Hospital

入排标准

入选标准

  • (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.

排除标准

  • (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.

研究组 & 干预措施

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.

干预措施: 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 CKD patient group, to establish baseline viscoelasticity parameters for comparison with the CKD patients.

干预措施: Magnetic Resonance Imaging

结局指标

主要结局

Annual rate of eGFR decline

时间窗: 24 months

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

研究点 (1)

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