Actively Recruiting
Non-invasive Evaluation of Kidneys in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) Using Ultrasound Localization Microscopy
Led by University of Erlangen-Nürnberg Medical School · Updated on 2025-09-17
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to non-invasively visualize kidney perfusion, small blood vessels, and individual glomeruli using Ultrasound Localization Microscopy (ULM) and contrast-enhanced ultrasound (CEUS) in children with congenital anomalies of the kidney and urinary tract (CAKUT). CAKUT affects about 0.5% of newborns and is a major cause of chronic kidney failure, dialysis needs, and increased health risks. The study seeks better imaging methods to assess kidney damage and disease progression beyond current tests. Children under 6 years old with CAKUT who are scheduled for MAG3 scintigraphy will be included. After the routine kidney scintigraphy, participants will undergo CEUS imaging with the injection of a contrast agent during ultrasound to enhance kidney tissue visualization. ULM post-processing will then analyze the microvascular structure and kidney perfusion. The study compares these advanced imaging methods to current diagnostic tools and may improve understanding of kidney function and damage. Participants will be monitored at baseline and followed up 1 to 31 days after any routine surgery if indicated. The research includes multiple CEUS and ULM measurements to visualize and quantify kidney blood flow, microvasculature, and glomeruli. Kidney function will also be assessed through laboratory tests. The study involves non-invasive imaging and data collection to evaluate kidney health and perfusion, aiming to provide new diagnostic information for children with CAKUT.
CONDITIONS
Brief Title
Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 month and 6 years
- Indication for MAG3 scintigraphy of the kidney
- Diagnosis of congenital anomalies of the kidney and urinary tract obstruction
- Availability of a qualified examiner
- Consent of the parents or legal guardians
You will not qualify if you...
- Lack of consent from at least one parent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo routine MAG3 scintigraphy to assess kidney function as part of their clinical care.
1 visit (in-person)
Duration - Baseline and follow-up within 1 to 31 days after routine surgery if indicated
Participants receive contrast enhanced ultrasound imaging (CEUS) with Ultrasound Localization Microscopy (ULM) to visualize and quantify kidney perfusion and microvascular structure following the MAG3 scintigraphy.
1 baseline visit and 1 follow-up visit
Duration - Up to 31 days after routine surgery if indicated
Participants are monitored through imaging and laboratory assessments to evaluate kidney function and tissue perfusion over time.
Additional visits may occur depending on clinical needs
Trial Site Locations
Total: 1 location
1
FAU Erlangen-Nuernberg,
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
R
Regensburger Regensburger, PD Dr. med. Dr. rer. biol. Hum
D
Dr. med. Alina Hilger
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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