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NCT Number: NCT07113808

Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China

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.

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Key information

Conditions

Abdominal Neoplasm Abdominal Injuries Abdominal Injury Abdominal Neoplasms Ascites Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location status: Recruiting

Location contact

YE JJ Director of the Ultrasound Department

CONTACT

[email protected]

+8613868174280

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Heart disease with right-to-left shunt/severe pulmonary hypertension /uncontrolled systemic hypertension/respiratory failure/heart failure/severe arrhythmia;
  • Electrocardiogram, echocardiography or clinical manifestations of myocardial ischemia;
  • Patients with severe blood system diseases or infectious diseases;
  • Hypercoagulable state and recent history of thrombosis;
  • Severe hepatic and renal insufficiency;
  • Patients with respiratory tract infection or congenital respiratory malformation.

Treatment and study plan

contrast-enhanced ultrasound examination

Device

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®

Drug

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

Primary outcomes

  1. sensitivity

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

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

  2. specificity

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

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

  3. Positive predictive value

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

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

  4. Negative predictive value

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

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

Other outcomes

  1. adverse event rate

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

YE JJ Director of the Ultrasound Department

CONTACT

[email protected]

+8613868174280

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Collaborators

  • Children's Hospital of Chongqing Medical University
  • Kunming Children's Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Shenzhen Children's Hospital
  • Tianjin Children's Hospital
  • West China Hospital
  • Xian Children's Hospital
  • Yuying Children's Hospital of Wenzhou Medical University

Registry information

Official study title

Clinical Medical Quality Control Management of Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China: A Multi-Center Study

Acronym: CEUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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