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Recruiting Observational

Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China

NCT07113808 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-09-10
Last updated
2025-12-08

Condition(s) studied

Abdominal NeoplasmAbdominal InjuryAscites

Investigational drug(s) / intervention(s)

contrast-enhanced ultrasound examinationSonoVue® →

contrast-enhanced ultrasound examination: to evaluate the the application of contrast-enhanced ultrasound examination in children with intra-abdominal diseases that require clear diagnoses aged from 29 days to 18 years old

SonoVue®: perform contrast enhanced ultrasound (CEUS) using Sonovue as the contrast agent

Study summary

The goal of this clinical trial is to evaluate the application of intravenous contrast-enhanced ultrasound examination in children with intra-abdominal diseases that require clear diagnoses. The main questions it aims to answer are:

* Is intravenous contrast-enhanced ultrasound helpful for the diagnosis of intra-abdominal diseases in children?
* What medical problems do participants have when participating in intravenous contrast-enhanced ultrasound examination?
* How can ultrasound doctors conduct intravenous contrast-enhanced ultrasound examinations in a standardized manner? Researchers will performing intravenous contrast-enhanced ultrasound examinations on participants and collecting research subjects to establish a multicenter clinical data database.

Participants will:

* Perform abdominal ultrasound examination to assess the condition.
* At least conduct one intravenous contrast-enhanced ultrasound examination. Based on the result of the contrast examination, decide whether to conduct another examination.
* Keep a diary of their symptoms and therapeutic process in 30 days.

Eligibility

Sex
ALL
Min age
29 Days
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 29 days to 18 years old; 2. The clinical diagnosis was abdominal space-occupying lesions, blunt abdominal trauma, ascites of unknown cause, and children with suspected abdominal disease but other examinations could not identify the cause. Exclusion Criteria: 1. Allergic to sulfur hexafluoride or other components; 2. Heart disease with right-to-left shunt/severe pulmonary hypertension /uncontrolled systemic hypertension/respiratory failure/heart failure/severe arrhythmia; 3. Electrocardiogram, echocardiography or clinical manifestations of myocardial ischemia; 4. Patients with severe blood system diseases or infectious diseases; 5. Hypercoagulable state and recent history of thrombosis; 6. Severe hepatic and renal insufficiency; 7. Patients with respiratory tract infection or congenital respiratory malformation.

Primary outcome measure(s)

  • sensitivity — Thirty days after the last venous ultrasound contrast examination
    to calculate the sensitivity of venous contrast-enhanced ultrasound examination in children
  • specificity — Thirty days after the last venous ultrasound contrast examination
    to calculate the specificity of venous contrast-enhanced ultrasound examination in children
  • Positive predictive value — Thirty days after the last venous ultrasound contrast examination
    to calculate the positive predictive value of venous contrast-enhanced ultrasound examination in children
  • Negative predictive value — Thirty days after the last venous ultrasound contrast examination
    to calculate the negative predictive value of venous contrast-enhanced ultrasound examination in children

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07113808 on ClinicalTrials.gov ↗ ← All trials in China