The Children's Hospital of Zhejiang University School of Medicine
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)
Facility
City
Region
Status
Children's Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More The Children's Hospital of Zhejiang University School of Medicine trials in China
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.
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