Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age29-18
SponsorThe Children's Hospital of Zhejiang University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
contrast-enhanced ultrasound examination
Deviceto 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®
Drugperform contrast enhanced ultrasound (CEUS) using Sonovue as the contrast agent
Treatment groups
No treatment groups listed
Trial outcomes
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 examination2
specificity
to calculate the specificity of venous contrast-enhanced ultrasound examination in children
Time frame
Thirty days after the last venous ultrasound contrast examination3
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 examination4
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 examinationOther 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 examinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Children's Hospital of Zhejiang University School of Medicine
Lead sponsor
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
West China Hospital
Collaborator
Yuying Children's Hospital of Wenzhou Medical University
Collaborator
Xian Children's Hospital
Collaborator
Source ClinicalTrials.gov