About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known allergic disposition to SonoVue®
Contraindication to the use of SonoVue®
Pregnancy
Breastfeeding mothers
Trial population
One study population. Anticipated approx. n=30 adultswith above mentioned inclusion criteria with active sediment and/or proteinuria and indication for kidney biopsy
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
CEUS Time intensity curves
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
CEUS Measurement1
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
Description: WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
CEUS Measurement 3
RT (Rise Time = arterial inflow until maximum signal intensity), measured in seconds, higer RT means faster arterial inflow
Secondary outcomes
ULM and Ultrasound
Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with sonographic parameters (including resistance index a.o.)
ULM and CEUS
Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with parameters of contrast-enhanced ultrasound (CEUS)
ULM and biopsy
Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (including the number of segmented glomeruli) with histological parameters.
2D and 3D ULM
Comparison of visualized and quantified microvascular dynamics (including glomeruli) using 2D and 3D ULM
Other outcomes
urinary status
levels of erythrocytes and proteinuria in urine, microscopic examination of urine sediment
Sponsors and contacts
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