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

ConditionNephritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Study group

Trial outcomes

Primary outcomes

1

CEUS Time intensity curves

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

Time frame
baseline and up to 10 weeks after baseline
2

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.

Time frame
baseline and up to 10 weeks after baseline
3

CEUS Measurement2

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

Time frame
Baseline and up to 10 weeks after baseline
4

CEUS Measurement 3

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

Time frame
Baseline and up to 10 weeks after baseline

Secondary outcomes

1

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.)

Time frame
Baseline and up to 10 weeks after baseline
2

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)

Time frame
Baseline and up to 10 weeks after baseline
3

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.

Time frame
Baseline and up to 10 weeks after baseline
4

2D and 3D ULM

Comparison of visualized and quantified microvascular dynamics (including glomeruli) using 2D and 3D ULM

Time frame
Baseline and up to 10 weeks after baseline

Other outcomes

1

urinary status

levels of erythrocytes and proteinuria in urine, microscopic examination of urine sediment

Time frame
Baseline and up to 10 weeks after baseline

Sponsors and contacts

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