Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China (NCT07113808) | Clinical Trial Compass
RecruitingNot Applicable
Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China
China108 participantsStarted 2024-09-10
Plain-language 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.
Who can participate
Age range
29 Days – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 29 days to 18 years old;
. 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
. Allergic to sulfur hexafluoride or other components;
. Electrocardiogram, echocardiography or clinical manifestations of myocardial ischemia;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
sensitivity
Timeframe: Thirty days after the last venous ultrasound contrast examination
2
specificity
Timeframe: Thirty days after the last venous ultrasound contrast examination
3
Positive predictive value
Timeframe: Thirty days after the last venous ultrasound contrast examination
4
Negative predictive value
Timeframe: Thirty days after the last venous ultrasound contrast examination
Trial details
NCT IDNCT07113808
SponsorThe Children's Hospital of Zhejiang University School of Medicine