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Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)

ConditionsCongenital Anomalies of Kidney and Urinary Tract Lower Urinary Tract Obstruction, Congenital Ureteropelvic Junction Obstruction Hydronephrosis Congenital

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-6

SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

This clinical study aims to non-invasively visualize perfusion and microvascularization, as well as individual glomeruli, using Ultrasound Localization Microscopy (ULM) and CEUS in patients with congenital anomalies of the kidney and urinary tract (CAKUT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

One study population. Anticipated approx. n=20 children with above mentioned inclusion criteria with congenital anomalies of the kidney and urinary tract and inclusion criteria for MAG3 scintigraphy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
Device
CEUS is a contrast based ultrasound technique and ULM (Ultrasound Localization Microscopy) is a post-processing bioinformatical method to quantify microvascular architecture and perfusion dynamics.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Children with congenital anomalies of the kidney and urinary tract (CAKUT) with indication for MAG31 intervention

Trial outcomes

Primary outcomes

1

CEUS Measurement1

PE (Peak-Enhancement)

Time frame

Baseline and follow up (1-31 days after routine surgery if indicated)

2

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 follow up (1-31 days after routine surgery if indicated)

3

CEUS Measurement2

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

Time frame

Baseline and follow up (1-31 days after routine surgery if indicated)

4

CEUS Measurement4

RT (Rise Time)

Time frame

Baseline and follow up (1-31 days after routine surgery if indicated)

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 (RI), flow velocity).

Time frame

Baseline and follow up (1-31 days after routine surgery if indicated)

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 follow up (1-31 days after routine surgery if indicated)

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 follow up (1-31 days after routine surgery if indicated)

4

ULM on affected and unaffected kidney

Comparison of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) between the affected and unaffected kidney in the same patient.

Time frame

Baseline and follow up (1-31 days after routine surgery if indicated)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Erlangen-Nürnberg Medical School

Lead sponsor

University Hospital Erlangen

Sponsor institution

Source ClinicalTrials.gov