Intravenous contrast-enhanced ultrasound for diagnosing children's abdominal problems in China
Clinical Medical Quality Control Management of Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China: A Multi-Center Study
This project will try intravenous contrast-enhanced ultrasound in children (29 days–18 years) with abdominal tumors, injuries, or unexplained fluid to see if it gives clearer diagnoses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 108 (estimated) |
| Ages | 29 Days to 18 Years |
| Sex | All |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07113808 on ClinicalTrials.gov |
What this trial studies
This multicenter observational project will perform routine abdominal ultrasound and at least one intravenous contrast-enhanced ultrasound (CEUS) in pediatric patients who need clearer intra-abdominal diagnoses. Clinicians will record imaging findings, any medical problems during CEUS, and procedural details to support development of standardized examination protocols. Data from participating hospitals will be combined into a multicenter clinical database for analysis. Clinical decisions about further care will follow CEUS results and usual clinical judgment.
Who should consider this trial
Good fit: Children aged 29 days to 18 years with abdominal space-occupying lesions, blunt abdominal trauma, unexplained ascites, or suspected abdominal disease not identified by other tests are ideal candidates.
Not a fit: Patients allergic to sulfur hexafluoride, with significant cardiopulmonary disease, severe blood disorders, hypercoagulable states, severe hepatic or renal failure, respiratory infections or congenital airway malformations, or those already having a definitive diagnosis are unlikely to benefit.
Why it matters
Potential benefit: If successful, CEUS could provide clearer, noninvasive imaging for pediatric abdominal conditions and reduce the need for more invasive or radiation-based tests.
How similar studies have performed: Previous single-center and adult CEUS studies have shown promising results for liver lesions and trauma, but multicenter pediatric evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: YE JJ Director of the Ultrasound Department
- Email: 6195005@zju.edu.cn
- Phone: +8613868174280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.