Clinical trial · Observational
Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China
Clinical Medical Quality Control Management of Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China: A Multi-Center Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Injury | — | UNRESOLVED | — |
| Abdominal Neoplasm | — | UNRESOLVED | — |
| Ascites | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| contrast-enhanced ultrasound examination | Device | — | UNRESOLVED |
| SonoVue® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- sensitivity
- timeFrame
- Thirty days after the last venous ultrasound contrast examination
- description
- to calculate the sensitivity of venous contrast-enhanced ultrasound examination in children
- measure
- specificity
- timeFrame
- Thirty days after the last venous ultrasound contrast examination
- description
- to calculate the specificity of venous contrast-enhanced ultrasound examination in children
- measure
- Positive predictive value
- timeFrame
- Thirty days after the last venous ultrasound contrast examination
- description
- to calculate the positive predictive value of venous contrast-enhanced ultrasound examination in children
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 29 Days
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available