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临床试验/NCT07469059
NCT07469059招募中不适用

Characterization of Renal Microvascular Alterations in Patients With Active Urinary Sediment and/or Proteinuria Using Ultrasound Localization Microscopy

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
CEUS Measurement9

研究概览

简要总结

The goal of this study is the non-invasive visualization and quantification of renal microvascular dynamics in adult kidneys with proteinuria and/or active sediment.

详细描述

In this study, the microvascular architecture of the kidney in adults with active urinary sediment or proteinuria is to be examined non-invasively using Ultrasound Localization Microscopy (ULM).

Kidney diseases can broadly be classified according to the affected nephron compartment into glomerular, tubular, and tubulointerstitial diseases. Glomerular diseases include, among others, the nephrotic and nephritic syndromes, which differ in their clinical and laboratory characteristics: while the nephrotic syndrome is typically characterized by marked proteinuria (>3.5 g/day), hypoalbuminemia, edema, and hyperlipidemia, the nephritic syndrome is dominated by hematuria with acanthocytes, mild to moderate proteinuria, arterial hypertension, and impaired renal function. Tubular and tubulointerstitial diseases, on the other hand, often manifest as acute kidney injury (e.g., in ischemic or toxic injury), polyuria, salt wasting, or metabolic acidosis, often accompanied by nonspecific symptoms such as fatigue or dehydration.

In addition to these classical nephron compartments, renal vascular structures may also be primarily or secondarily affected, as in vasculitis, thrombotic microangiopathies, or hypertensive nephropathy. Although these vascular structures are not directly part of the nephron, they are functionally closely linked to it and have a significant impact on renal function.

To assess kidney status, pathophysiology, and the site of injury non-invasively, urinary sediment is analyzed. Urinary sediment represents a central diagnostic tool that provides information on the localization of kidney damage, thereby functioning as a type of "liquid biopsy."

If there is clinical suspicion of acute or rapidly progressive renal failure, nephrotic syndrome, significant non-nephrotic proteinuria, glomerular hematuria, or if a systemic disease with possible renal involvement is present, a kidney biopsy is usually indicated for further diagnostic clarification. Obtaining tissue samples for histological examination is an invasive procedure associated with inpatient hospitalization, considerable burden for patients, and potential complications. Currently, alternative imaging methods cannot replace kidney biopsy. Furthermore, CT, PET, or MR imaging is associated with radiation exposure or considerable additional effort (e.g., sedation).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Evidence of active urinary sediment and/or proteinuria >1 g/g creatinine
  • Indication for kidney biopsy as part of study-independent diagnostics
  • Written informed consent

排除标准

  • Known allergic disposition to SonoVue®
  • Contraindication to the use of SonoVue®
  • Pregnancy
  • Breastfeeding mothers

研究组 & 干预措施

Study group

Patients with active sediment and/or proteinuria (>1g/g Krea) and indication for renal biopsy

结局指标

主要结局

CEUS Measurement9

时间窗: Baseline and up to 10 weeks after baseline

WoAUC (Wash-out AUC (AUC(TTP:TO)))

CEUS Time intensity curves

时间窗: baseline and up to 10 weeks after baseline

All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis

CEUS Measurement1

时间窗: baseline and up to 10 weeks after baseline

PE (Peak-Enhancement) is an established measurement in CEUS analysis. It describes the highest signal intensity after administration of contrast agents and is measured in arbitrary units. All CEUS measurements are established measurements in Time intensity analysis (TIC) of contrast enhanced ultrasound data.

CEUS Measurement2

时间窗: Baseline and up to 10 weeks after baseline

Description: WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))

CEUS Measurement 3

时间窗: Baseline and up to 10 weeks after baseline

RT (Rise Time = arterial inflow until maximum signal intensity), measured in seconds, higer RT means faster arterial inflow

CEUS Measurement5

时间窗: Baseline and up to 10 weeks after baseline

mTT (mean Transit Time local) (mTT-TI))

CEUS Measurement6

时间窗: Baseline and up to 10 weeks after baseline

TTP (Time to Peak)

CEUS Measurement7

时间窗: Baseline and up to 10 weeks after baseline

WiR (Wash-in-Rate )

CEUS Measurement8

时间窗: Baseline and up to 10 weeks after baseline

WiPI (Wash-in Perfusion Index (WiAUC/RT))

CEUS Measurement10

时间窗: Baseline and up to 10 weeks after baseline

WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))

CEUS Measurement11

时间窗: Baseline and up to 10 weeks after baseline

FT (Fall Time - (TO-TTP))

CEUS Measurement12

时间窗: Baseline and up to 10 weeks after baseline

WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)

CEUS Measurement13

时间窗: Baseline and up to 10 weeks after baseline

QOF (Quality Of Fit between the echo-power signal and f(t)

Visualization and quantification of kidney perfusion with CEUS

时间窗: Baseline and up to 10 weeks after baseline

CEUS imaging for kidney perfusion in kidney disease

Visualization and quantification of kidney mikrovaskularisation with ULM

时间窗: Baseline and up to 10 weeks after baseline

ULM imaging for kidney perfusion and microvaskularisation in kidney disease

Visualization and quantification of glomeruli in the kidney with ULM

时间窗: Baseline and up to 10 weeks after baseline

ULM imaging for glomeruli in the kidney

次要结局

  • Assessment of renal function urea(Baseline and up to 10 weeks after baseline)
  • ULM and Ultrasound(Baseline and up to 10 weeks after baseline)
  • ULM and CEUS(Baseline and up to 10 weeks after baseline)
  • ULM and biopsy(Baseline and up to 10 weeks after baseline)
  • 2D and 3D ULM(Baseline and up to 10 weeks after baseline)
  • ULM and diagnosis(Baseline and up to 10 weeks after baseline)
  • Comparison before and after treatment(Baseline and up to 10 weeks after baseline)
  • Correlation between ULM and laboratory parameters(Baseline and up to 10 weeks after baseline)
  • ULM on different diagnoses(Baseline and up to 10 weeks after baseline)
  • Assessment of renal function GFR(Baseline and up to 10 weeks after baseline)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferdinand Knieling

PD Dr. med. Dr. rer. biol. hum. Ferdinand Knieling MHBA

University of Erlangen-Nürnberg Medical School

研究点 (1)

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