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Recruiting NCT07113808

Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China

— Observational Abdominal Neoplasm Abdominal Injury Ascites

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: contrast-enhanced ultrasound examination, SonoVue®.
Who it may be relevant to
Registry conditions: Abdominal Neoplasm, Abdominal Injury, Ascites. Basic parameters: 29 Days — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device contrast-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
  • Drug SonoVue®
    perform contrast enhanced ultrasound (CEUS) using Sonovue as the contrast agent

Primary outcome measures

  • sensitivity [Time frame: Thirty days after the last venous ultrasound contrast examination]
  • specificity [Time frame: Thirty days after the last venous ultrasound contrast examination]
  • Positive predictive value [Time frame: Thirty days after the last venous ultrasound contrast examination]
  • Negative predictive value [Time frame: Thirty days after the last venous ultrasound contrast examination]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Children's Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07113808 · JiYe

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗