Congenital Anomalies of Kidney and Urinary TractSearch_CAKUTNCT06921733
Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
An observational study of Congenital Anomalies of Kidney and Urinary Tract and Lower Urinary Tract Obstruction, Congenital, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 months to 6 years
- Conditions the study is for
- Congenital Anomalies of Kidney and Urinary Tract, Lower Urinary Tract Obstruction, Congenital, Ureteropelvic Junction Obstruction
- What is being tested?
- Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 13 May 2025to 1 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 6 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Lack of consent of at least one parent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Regensburger Regensburger, PD Dr. med. Dr. rer. biol. Hum contact
Dr. med. Alina Hilger contact
Germany1 site, 1 recruiting
- Recruiting
FAU Erlangen-Nuernberg,
Erlangen, Bavaria, 91054
PD Dr. med. Dr. rer. biol. Hum. Adrian Regensburger, adrian.regensburger@uk-erlangen.de
Dr. med. Alina Hilger, alina.hilger@uk-erlangen.de
About this study
Official title: Non-invasive Evaluation of Kidneys in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) Using Ultrasound Localization Microscopy
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).
Read the 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.
- Conditions
- Congenital Anomalies of Kidney and Urinary Tract, Lower Urinary Tract Obstruction, Congenital, Ureteropelvic Junction Obstruction, Hydronephrosis Congenital
- Being tested
- Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
- Medical subject headings
- Cakut, Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasound imaging (CEUS) and post processing with ULMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with congenital anomalies of the kidney and urinary tract (CAKUT) with indication for MAG3 | Included will be children under the age of 6 with congenital anomalies of the kidney and urinary tract (CAKUT)that get an indication for a MAG3 scintigraphy. They will be monitored with CEUS/ULM after the MAG3 scintigraphy. Receives: Device: Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEUS Measurement1
PE (Peak-Enhancement)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Time intensity curves
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement2
WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement4
RT (Rise Time)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement5
mTT (mean Transit Time local) (mTT-TI))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement6
TTP (Time to Peak)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement7
WiR (Wash-in-Rate )
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement8
WiPI (Wash-in Perfusion Index (WiAUC/RT))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement9
WoAUC (Wash-out AUC (AUC(TTP:TO)))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement10
WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement11
FT (Fall Time - (TO-TTP))
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement12
WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
CEUS Measurement13
QOF (Quality Of Fit between the echo-power signal and f(t)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Visualization and quantification of kidney perfusion with CEUS
CEUS imaging for kidney perfusion in CAKUT
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Visualization and quantification of kidney mikrovaskularisation with ULM
ULM imaging for kidney perfusion and mikrovaskularisation in CAKUT
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Visualization and quantification of glomeruli in the kidney with ULM
ULM imaging for glomeruli in the kidney
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Secondary outcomes (15)
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).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
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).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
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.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
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.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM and Scintigraphy
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 from renal scintigraphy (e.g., perfusion parameters).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Pressure changes with CEUS
Visualization of pressure changes in the kidney using the vascular architecture visualized by CEUS and parameters of quantified microvascular perfusion dynamics.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Pressure changes with ULM
Visualization of pressure changes in the kidney using the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Comparison of the kidney before and after intervention with ULM
Comparison of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) before and after intervention
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM on different diagnoses
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 different diagnoses.
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
ULM on clinical outcomes
Correlation and comparison of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with clinical criteria and clinical outcomes (surgical success).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Correlation between ULM and laboratory parameters
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 laboratory parameters (including kidney function parameters, inflammatory markers, and immunological parameters).
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function GFR
GFR (ml/min/1,73 m2)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function urea
urea (mg/dl)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Assessment of renal function urinary status
standardized urinary status
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Assesment of renal function kreatininekinase
kreatininekinase (U/l)
Measured: Baseline and follow up (1-31 days after routine surgery if indicated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start13 May 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Anomalies of Kidney and Urinary TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinand Knieling, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921733
- Sponsor's protocol ID
- Search_CAKUT_ULM
- Acronym
- Search_CAKUT
- Status last verified
- Sep 2025
- First submitted
- 21 Oct 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No