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Study on Diagnosing Vesicoureteral Reflux in Children Using Sulfur Hexafluoride and Technetium (99mTc)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called vesicoureteral reflux in children. Vesicoureteral reflux is a condition where urine flows backward from the bladder towards the kidneys, which can lead to urinary tract infections. The study aims to find out how well two different methods can diagnose this condition. The first method is called Direct Isotope Cystography, which uses a special substance called technetium (99mTc) to create images of the bladder. The second method is Contrast Enhanced Voiding Ultrasonography, which uses a substance called sulfur hexafluoride to enhance ultrasound images.

The purpose of the study is to determine the accuracy of these methods in detecting vesicoureteral reflux. Children participating in the study will undergo both diagnostic procedures. The study will compare the results to see which method is more effective in identifying the condition. The procedures involve injecting the substances into the bladder through a small tube, and then taking images while the bladder is being emptied.

This study is important for improving the diagnosis of vesicoureteral reflux in children, which can help in managing and treating the condition more effectively. The trial will provide valuable information on the best way to detect this condition, potentially leading to better outcomes for affected children.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves children under 6 years old who have experienced at least two urinary tract infections confirmed by culture.

    The main goal is to diagnose vesicoureteral reflux, a condition where urine flows backward from the bladder to the kidneys.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility and gather baseline health information.

  3. Step 3

    Administration of SonoVue

    The child will receive an injection of SonoVue, a dispersion for injection, administered intravesically. This means it is introduced directly into the bladder.

  4. Step 4

    Administration of Ultra-TechneKow FM

    Following the SonoVue injection, Ultra-TechneKow FM, a solution for injection, will also be administered intravesically. This is a radionuclide generator used for imaging purposes.

  5. Step 5

    Imaging procedures

    The child will undergo imaging procedures, including direct isotope cystography and contrast-enhanced voiding ultrasonography, to detect vesicoureteral reflux.

  6. Step 6

    Evaluation of results

    The primary endpoint is to determine the presence or absence of vesicoureteral reflux based on the imaging results.

  7. Step 7

    Completion of study participation

    The study is estimated to conclude by May 15, 2030. Participation will end after the final evaluation of the imaging results.

Who can join the trial?

3 criteria

  • Patients must be **under 6 years old**.
  • Patients must have had at least **2 urinary tract infections** that were confirmed by a lab test called a **culture**.
  • Both **boys and girls** can participate.

Who cannot join the trial?

1 criterion

  • There are no specific reasons listed that would prevent a patient from participating in this study.
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Investigated drugs

  • Direct Isotope Cystography

    is a diagnostic imaging technique used to detect vesicoureteral reflux in children. It involves the use of a small amount of radioactive material to create images of the bladder and ureters, helping doctors see if urine is flowing backward from the bladder into the kidneys.

  • Contrast Enhanced Voiding Ultrasonography (CEVUS)

    is another imaging method used to diagnose vesicoureteral reflux. This technique uses ultrasound along with a special contrast agent that is introduced into the bladder. The contrast agent helps to create clearer images, allowing doctors to see if there is any backward flow of urine from the bladder to the kidneys.

What is already known about the treatment

Contrast Enhanced Voiding Ultrasonography (CEVUS) – This diagnostic method is used to detect vesicoureteral reflux, a condition where urine flows backward from the bladder to the kidneys. CEVUS is administered through a non-invasive ultrasound procedure, which involves the use of a contrast agent to enhance imaging. Currently, it is being evaluated in clinical trials for its accuracy in diagnosing this condition in children. The technique is gaining attention in medical literature as a safer alternative to traditional methods, offering clear visualization without radiation exposure. CEVUS falls under the category of diagnostic imaging techniques, focusing on improving the detection and management of urinary tract disorders.

Investigated diseases

Vesicoureteral Reflux – Vesicoureteral reflux is a condition where urine flows backward from the bladder into the ureters and sometimes into the kidneys. This backward flow can occur when the valve mechanism at the junction of the ureter and bladder is not functioning properly. It is most commonly seen in children and can lead to urinary tract infections. Over time, repeated infections can cause kidney damage if not managed. The severity of the reflux can vary, with some cases resolving as a child grows. In more severe cases, the condition may persist and require monitoring.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-518974-15-01Estimated enrolment100 patientsSponsorTurku University Hospital

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