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RecruitingNCT07113808CEUSUpdated Dec 8, 2025

Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China

An observational study in Abdominal Neoplasm, Abdominal Injury and Ascites, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 29 Days to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
108
Ages
29 Days to 18 Years
Sex
All
01

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.
02

Conditions studied

  • Abdominal Neoplasm
  • Abdominal Injury
  • Ascites
03

Who can participate

Ages eligible
29 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients in Children's Hospital Affiliated to Zhejiang University School of Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Shenzhen Children's Hospital, West China Hospital of Sichuan University, Children's Hospital of Chongqing Medical University, Tianjin Children's Hospital, Xi 'an Children's Hospital, Yuying Children's Hospital Affiliated to Wenzhou Medical University, Kunming Children's Hospital.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
108 participants (estimated)
Patient registry
No

Interventions

  • Devicecontrast-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

  • DrugSonoVue®

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

05

What researchers measure

Primary outcomes

  1. sensitivity

    to calculate the sensitivity of venous contrast-enhanced ultrasound examination in children

    Time frame: Thirty days after the last venous ultrasound contrast examination

  2. specificity

    to calculate the specificity of venous contrast-enhanced ultrasound examination in children

    Time frame: Thirty days after the last venous ultrasound contrast examination

  3. Positive predictive value

    to calculate the positive predictive value of venous contrast-enhanced ultrasound examination in children

    Time frame: Thirty days after the last venous ultrasound contrast examination

  4. Negative predictive value

    to calculate the negative predictive value of venous contrast-enhanced ultrasound examination in children

    Time frame: Thirty days after the last venous ultrasound contrast examination

Other outcomes

  1. adverse event rate

    to calculate the adverse event rate of venous contrast-enhanced ultrasound examination in children

    Time frame: Thirty days after the last venous ultrasound contrast examination

06

Study locations

1 of 1 sites recruiting
  • Children's Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310052, China
    • YE JJ Director of the Ultrasound Department · Contact · 6195005@zju.edu.cn · +8613868174280
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07113808
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
Collaborators
Shenzhen Children's Hospital, Children's Hospital of Chongqing Medical University, Tianjin Children's Hospital, Kunming Children's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, West China Hospital, Yuying Children's Hospital of Wenzhou Medical University, Xian Children's Hospital
Responsible party
Jingjing Ye (Director of the Ultrasound Department, The Children's Hospital of Zhejiang University School of Medicine) — Principal investigator
First posted
Aug 11, 2025
Start date
Sep 10, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Dec 8, 2025

Study contacts

YE JJ Director of the Ultrasound Department
Contact
6195005@zju.edu.cn
+8613868174280

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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