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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

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
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

In context

Abdominal Neoplasms

42 studies on the registry are indexed under Abdominal Neoplasms; 14 are open to participants now.

This study's planned enrollment of 108 is close to the median of 104 across 14 observational studies indexed under Abdominal Neoplasms.

Browse Abdominal Neoplasms studies →

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Sep 2026, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2025
First posted
Aug 11, 2025
StartActual
Sep 10, 2024
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Dec 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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