Clinical trial NCT06921733: Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
Official title: Non-invasive Evaluation of Kidneys in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) Using Ultrasound Localization Microscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Anomalies of Kidney and Urinary Tract
Lower Urinary Tract Obstruction, Congenital
Ureteropelvic Junction Obstruction
Hydronephrosis Congenital
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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).

Detailed description: Congenital anomalies of the kidney and urinary tract (CAKUT) affect 0.5% of newborns and account for 20% of all congenital malformations. These conditions are associated with chronic kidney failure, a need for dialysis, and significantly increased mortality (30 times higher than healthy peers) and morbidity. Patients with CAKUT face substantial health and socioeconomic burdens due to lifelong therapy requirements. In Europe, CAKUT is the leading cause of dialysis-dependent chronic kidney failure.

All CAKUT disorders arise in utero, interfering with kidney development and leading to reduced nephron formation. Many congenital kidney anomalies are diagnosed via prenatal ultrasound. These anomalies include ureteropelvic junction obstruction, often presenting as unilateral hydronephrosis, and posterior urethral valves, which can be associated with megacystis and bilateral hydronephrosis. The resulting urinary obstruction can cause pressure damage to kidney tissue during fetal development, further reducing functional nephron mass. Postnatally, ongoing pressure damage can lead to renal remodeling. The decreased nephron mass and remodeling increase the long-term risk of kidney insufficiency, which is currently assessed only by serum creatinine levels-these are delayed and less sensitive in infants and young children. Reliable biomarkers for reduced nephron mass or renal remodeling to predict chronic kidney injury risk in CAKUT patients are currently lacking. Currently, the actual pressure impact of sonographically detectable urinary obstruction can only be assessed through urine flow patterns using MAG-3 scintigraphy. However, this method is dependent on kidney function, which can affect the uptake and excretion of the radiopharmaceutical and subsequently influence the evaluation of results.

The intravenous use of ultrasound contrast enhancers as an aid opens up the possibility of recording the tissue perfusion of the kidneys, including the smallest vessels, independent of the kidney function. This could provide significantly more information compared to conventional methods and expand our knowledge of the pathophysiology and individual status of tissue perfusion in patients.

In this clinical study, the new CEUS measurement and imaging technique will be used after the kidney scintigraphy. A contrast agent (SonoVue®) will be administered during the routine ultrasound examination and improved tissue visualization will be achieved. The aim is to gain new insights into kidney perfusion as part of the treatment and to better assess the extent of organ damage in the individual patient through more specific vascular imaging. Finally, the aim is to compare diagnostic and prognostic methods with the currently recommended measures. The CEUS is to be examined as a possible diagnostic imaging tool and possibly a supplement to existing diagnostic methods.

Eligibility criteria: Inclusion Criteria:

Minimum Age 1 Month Maximum Age 6 Years Indication for MAG3 Scintigraphy of the Kidney Congenital Anomalies of the Kidney and Urinary Tract Obstruction Diagnosis Availability of the qualified examiner Consent of the parents/legal guardians

Exclusion Criteria:

Lack of consent of at least one parent

Primary outcomes:
measure: CEUS Measurement1
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Time intensity curves
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement2
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement4
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement5
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement6
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement7
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement8
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement9
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement10
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement11
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement12
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: CEUS Measurement13
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Visualization and quantification of kidney perfusion with CEUS
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Visualization and quantification of kidney mikrovaskularisation with ULM
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Visualization and quantification of glomeruli in the kidney with ULM
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
Secondary outcomes:
measure: ULM and Ultrasound
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: ULM and CEUS
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: ULM and Biopsy
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: ULM on affected and unaffected kidney
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: ULM and Scintigraphy
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Pressure changes with CEUS
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Pressure changes with ULM
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Comparison of the kidney before and after intervention with ULM
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: ULM on different diagnoses
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: ULM on clinical outcomes
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Correlation between ULM and laboratory parameters
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Assessment of renal function GFR
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Assessment of renal function urea
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Assessment of renal function urinary status
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
measure: Assesment of renal function kreatininekinase
timeFrame: Baseline and follow up (1-31 days after routine surgery if indicated)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: FAU Erlangen-Nuernberg,
state: Bavaria
Study officials:
References: