Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China

NCT ID: NCT07113808

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-10

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Neoplasm Abdominal Injury Ascites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

SonoVue®

perform contrast enhanced ultrasound (CEUS) using Sonovue as the contrast agent

Intervention Type DRUG

Eligibility Criteria

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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

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. Electrocardiogram, 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.
Minimum Eligible Age

29 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Tianjin Children's Hospital

OTHER

Sponsor Role collaborator

Kunming Children's Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Yuying Children's Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Xian Children's Hospital

OTHER_GOV

Sponsor Role collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jingjing Ye

Director of the Ultrasound Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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YE JJ Director of the Ultrasound Department

Role: CONTACT

+8613868174280

Facility Contacts

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YE JJ Director of the Ultrasound Department

Role: primary

+8613868174280

Other Identifiers

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JiYe

Identifier Type: -

Identifier Source: org_study_id

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