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

NCT06921733 | Recruiting

• 1 other identifier: Search_CAKUT_ULM
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (16)

• CEUS Measurement1

  PE (Peak-Enhancement)

  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

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

• CEUS Measurement2

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

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

• CEUS Measurement4

  RT (Rise Time)

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

• CEUS Measurement5

  mTT (mean Transit Time local) (mTT-TI))

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

• CEUS Measurement6

  TTP (Time to Peak)

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

• CEUS Measurement7

  WiR (Wash-in-Rate )

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

• CEUS Measurement8

  WiPI (Wash-in Perfusion Index (WiAUC/RT))

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

• CEUS Measurement9

  WoAUC (Wash-out AUC (AUC(TTP:TO)))

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

• CEUS Measurement10

  WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))

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

• CEUS Measurement11

  FT (Fall Time - (TO-TTP))

  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)

  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)

  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

  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

  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

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

Secondary Outcomes (15)

• ULM and Ultrasound

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

• ULM and CEUS

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

• ULM and Biopsy

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

• ULM on affected and unaffected kidney

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

• ULM and Scintigraphy

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

Study Arms (1)

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.

Device: Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM

Interventions

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.

Children with congenital anomalies of the kidney and urinary tract (CAKUT) with indication for MAG3

Eligibility Criteria

• Age: 0 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• Lack of consent of at least one parent

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

FAU Erlangen-Nuernberg,

Erlangen, Bavaria, 91054, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples

MeSH Terms

Conditions

Cakut; Multicystic renal dysplasia, bilateral

Central Study Contacts

Regensburger Regensburger, PD Dr. med. Dr. rer. biol. Hum

CONTACT

091318541732; adrian.regensburger@uk-erlangen.de

Dr. med. Alina Hilger

CONTACT

alina.hilger@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Dr. rer. biol. hum. Ferdinand Knieling

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: April 10, 2025
• Study Start: May 13, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)