Abdominal NeoplasmCEUSNCT07113808
Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China
An observational study of Abdominal Neoplasm and Abdominal Injury, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Abdominal Neoplasm, Abdominal Injury, Ascites
- What is being tested?
- contrast-enhanced ultrasound examination and SonoVue®
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
YE JJ Director of the Ultrasound Department, +8613868174280, 6195005@zju.edu.cn
About this study
Official title: Clinical Medical Quality Control Management of Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China: A Multi-Center Study
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.
Read more
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
- Being tested
- contrast-enhanced ultrasound examination, SonoVue®
- Medical subject headings
- Abdominal Neoplasms, Abdominal Injuries, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast-enhanced ultrasound examinationDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
to calculate the sensitivity of venous contrast-enhanced ultrasound examination in children
Measured: Thirty days after the last venous ultrasound contrast examination
specificity
to calculate the specificity of venous contrast-enhanced ultrasound examination in children
Measured: 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
Measured: 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
Measured: Thirty days after the last venous ultrasound contrast examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start10 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal NeoplasmStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Children's Hospital, Children's Hospital of Chongqing Medical University, Tianjin Children's Hospital, Kunming Children's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital, Yuying Children's Hospital of Wenzhou Medical University, Xian Children's Hospital
- Responsible party
- Principal investigator, Jingjing Ye, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113808
- Sponsor's protocol ID
- JiYe
- Acronym
- CEUS
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Medical Quality Control Management of Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China: A Multi-Center Study
- ClinicalTrials.gov ID
- NCT07113808
- Acronym / sponsor ID
- CEUS / JiYe
- Conditions
- Abdominal Neoplasm, Abdominal Injury, Ascites
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Shenzhen Children's Hospital, Children's Hospital of Chongqing Medical University, Tianjin Children's Hospital, Kunming Children's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital, Yuying Children's Hospital of Wenzhou Medical University, Xian Children's Hospital
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast-enhanced ultrasound examinationto 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 | Device | – |
| SonoVue®perform contrast enhanced ultrasound (CEUS) using Sonovue as the contrast agent | Drug | – |
Primary outcome
sensitivity
Time frame: Thirty days after the last venous ultrasound contrast examination
to calculate the sensitivity of venous contrast-enhanced ultrasound examination in children
specificity
Time frame: Thirty days after the last venous ultrasound contrast examination
to calculate the specificity of venous contrast-enhanced ultrasound examination in children
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Neoplasm and Abdominal Injury, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YE JJ Director of the Ultrasound Department (+8613868174280, 6195005@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: Thirty days after the last venous ultrasound contrast examination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.