Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China

NCT07113808 | Recruiting DMC FDA Drug

• 1 other identifier: JiYe
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Neoplasm; Abdominal Injury; Ascites

Outcome Measures

Primary Outcomes (4)

• sensitivity

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

  Thirty days after the last venous ultrasound contrast examination

• specificity

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

  Thirty days after the last venous ultrasound contrast examination

• Positive predictive value

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

  Thirty days after the last venous ultrasound contrast examination

• Negative predictive value

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

  Thirty days after the last venous ultrasound contrast examination

Other Outcomes (1)

• adverse event rate

  Thirty days after the last venous ultrasound contrast examination

Interventions

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

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

MeSH Terms

Conditions

Abdominal Neoplasms; Abdominal Injuries; Ascites

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

YE JJ Director of the Ultrasound Department

CONTACT

+8613868174280; 6195005@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Ultrasound Department

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 11, 2025
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)