3D ultrasound volumetry of the kidney parenchyma in childhood hydronephrosis and correlation to the side-separated kidney function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022772

Enrollment

100

Registered

2020-07-31

Start date

2021-02-26

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q62.0

Interventions

Group 1: Phase A The following steps are planned for the examination procedure: 1. Detailed clarification and obtaining the written consent for 3D volumetry and study participation on the day of the e

Eligibility

Sex/Gender

All

Age

No minimum to 16 Years

Inclusion criteria

Inclusion criteria: • Patients <16 years and their guardians • Presence of hydronephrosis • Assignment to ultrasound examination of the kidneys (phase A) • Assignment to 99mTc-MAG-3 kidney scintigraphy or MR urography (phase B) • Written consent to the study of the patient (depending on the stage of development) and the legal guardians

Exclusion criteria

Exclusion criteria: • Non-compliance of the patient • Generally valid contraindications for an MRI examination (only if no kidney scintigraphy is planned; phase B) • Incorrect measurement of kidney function in kidney scintigraphy and MR urography (phase B) • No written consent to the study of the patient (depending on the level of development) and the legal guardians

Design outcomes

Primary

Measure	Time frame
The primary goal of the study is to evaluate the use of a new type of 3D transducer with appropriate quantification software in the clinical routine for segmentation and volumetry of renal parenchymal volume in children with hydronephrosis and to determine inter- and intraobserver variability. The image data additionally acquired in the context of 3D sonography are processed after the examination using the quantification software, whereby the kidney volume is calculated. The study-related 3D measurements are not used for routine diagnostics. The image data collected are stored in the PACS. In the first phase A of the study, the feasibility and practicability of the method are evaluated in routine clinical practice. For this purpose, the data from 3D volumetry are compared to the conventional measurements of abdominal sonography. In addition, the inter- and intraobserver variability should be determined for the quantification of the kidney volumes using the Philips QLAB prototype kidney volume quantification software.	—

Measure

Time frame

The primary goal of the study is to evaluate the use of a new type of 3D transducer with appropriate quantification software in the clinical routine for segmentation and volumetry of renal parenchymal volume in children with hydronephrosis and to determine inter- and intraobserver variability. The image data additionally acquired in the context of 3D sonography are processed after the examination using the quantification software, whereby the kidney volume is calculated. The study-related 3D measurements are not used for routine diagnostics. The image data collected are stored in the PACS. In the first phase A of the study, the feasibility and practicability of the method are evaluated in routine clinical practice. For this purpose, the data from 3D volumetry are compared to the conventional measurements of abdominal sonography. In addition, the inter- and intraobserver variability should be determined for the quantification of the kidney volumes using the Philips QLAB prototype kidney volume quantification software.

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Secondary

Measure	Time frame
In the second step, the parenchymal volume measured using 3D ultrasound before and after i.v. administration of furosemide is to be correlated with the side-separated renal function within the scope of a clinically indicated kidney scintigraphy or MR urography carried out independently of the study. In study phase B, the change in volume of the kidney volume measured sonographically before and shortly after the intravenous administration of furosemide is given as the diuretic-dependent renal dilation volume (DRV). This volume is used as a predictor of Patlak-based side-separated kidney function. The volumes determined in this way are then to be correlated to the laterally separated kidney function. In this regard, MR urography and kidney scintigraphy are the reference standards for kidney function.	—

Measure

Time frame

In the second step, the parenchymal volume measured using 3D ultrasound before and after i.v. administration of furosemide is to be correlated with the side-separated renal function within the scope of a clinically indicated kidney scintigraphy or MR urography carried out independently of the study. In study phase B, the change in volume of the kidney volume measured sonographically before and shortly after the intravenous administration of furosemide is given as the diuretic-dependent renal dilation volume (DRV). This volume is used as a predictor of Patlak-based side-separated kidney function. The volumes determined in this way are then to be correlated to the laterally separated kidney function. In this regard, MR urography and kidney scintigraphy are the reference standards for kidney function.

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Countries

Germany

Contacts

Public ContactRebecca Leibfritz

Klinisches Studienmanagement Radiologische Klinik, Abteilung für Diagnostische und Interventionelle Radiologie Universitätsklinikum Tübingen

rebecca.leibfritz@med.uni-tuebingen.de07071 29-85841

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026