AuthorisedTherapeutic use (Phase IV)Interventional

Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography

This research is investigating how to best diagnose a condition called vesicoureteral reflux (VUR) in children. VUR is a common issue where urine flows backwards from the bladder to the kidneys, which can sometimes lead to kidney infections. The study is comparing two different methods for detecting VUR: a standard method that uses a special dye and X-rays (called isotope cystography), and a newer method that uses ultrasound with a special liquid to improve the scan. The main goal is to see if these tests can clearly tell if a child has VUR or not. This is an important step in helping doctors choose the best way to check for VUR in children, aiming for accurate and safe diagnosis.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Turku University Hospital

Enrolment target

100

Start

18 Nov 2024

Vesicoureteral reflux

What is this study about?

This study is focused on improving how doctors find out if a child has a condition called vesicoureteral reflux, or VUR. Imagine your urinary system as a series of pipes. When you wee, urine should flow in one direction, from your kidneys, down to your bladder, and then out of your body. With VUR, some of the urine flows the wrong way, back up from the bladder towards the kidneys. This can be a problem because it might lead to kidney infections.

Currently, there are different ways to check for VUR. This study is specifically comparing two methods. One method, called Isotope Cystography, uses a very small amount of a special, safe radioactive material that can be seen on a scan, along with X-rays. The other method, called Contrast Enhanced Voiding Ultrasonography, uses an ultrasound machine (like the one used to look at babies before they are born) combined with a special liquid that helps the doctor see the urine flow better.

The main aim of this research is to see which of these tests is better at clearly showing whether a child has VUR or not. This is important because finding VUR accurately can help doctors decide on the best treatment and prevent potential kidney problems. By understanding which test works best, doctors can make more informed decisions for children needing this diagnosis.

Key takeaways

The study aims to find the best way to diagnose vesicoureteral reflux (VUR) in children.
It compares two types of scans: special X-ray and enhanced ultrasound.
Children of all ages with suspected or diagnosed VUR can participate.
The research helps doctors make better decisions for diagnosing children with VUR.
Participation involves diagnostic scans with special imaging liquids.

Who may be eligible?

This study is open to both boys and girls of all ages, from babies right up to teenagers. Doctors will review your child's specific health information to make sure they can safely take part in the study.

Participation is considered if your child is suspected of having vesicoureteral reflux, or if they have already been diagnosed and doctors are reviewing the condition. There are no strict age limits, which means a wide range of children can be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child a boy or a girl?
Is your child currently being checked for vesicoureteral reflux (VUR)?
Has your child already been diagnosed with VUR?
Is your child of any age (from baby to teenager)?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve your child undergoing one or both of the diagnostic scans being compared: the special X-ray scan (Isotope Cystography) and/or the enhanced ultrasound scan (Contrast Enhanced Voiding Ultrasonography). These scans help doctors see if urine is flowing backwards. This research is part of what doctors call 'Phase IV', meaning the treatments and methods are already used in healthcare, but we are learning more about them.

For the ultrasound scan, a very small amount of a special liquid called SonoVue would be used. For the X-ray scan, a different special substance called Ultra-TechneKow FM would be used. The total duration of your child's participation would depend on the assessments and scans needed, but it would align with typical diagnostic procedures for VUR. You would receive detailed information about how many visits are needed and what each visit will involve.

Potential risks and benefits

Taking part in this study could offer your child the benefit of close monitoring and evaluation of their condition. The information gained will also help future children with VUR. Potential risks involved are generally small, related to the standard procedures of these diagnostic scans, such as minor discomfort during the scan or very rare reactions to the special liquids used. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is vesicoureteral reflux (VUR)?

VUR is when urine flows backwards from the bladder up towards the kidneys, which isn't how it should normally work. It can sometimes lead to kidney infections.

What are they testing in this study?

They are comparing two different types of scans to see which one works best at finding VUR in children: a special X-ray scan and an enhanced ultrasound scan.

Who can take part in this study?

Children of any age, boys or girls, who are being checked for VUR or have been diagnosed with it, might be able to join.

Will my child need to take medication?

Your child will receive special liquids (dyes) for the scans, but these are for imaging and not daily medication in the usual sense.

How long will the study participation last?

The study involves diagnostic tests, so the duration aligns with the time it takes to complete these scans and any necessary follow-up which would be explained to you in detail.