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Comparative study of the efficacy and safety of ultrasound contrast agent SonoVue in children with non cardiac ultrasound imaging

Comparative study of the efficacy and safety of ultrasound contrast agent SonoVue in children with non cardiac ultrasound imaging

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDD-16009238
Enrollment
Unknown
Registered
2016-09-21
Start date
2016-09-26
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse or focal lesions of non cardiac organs

Interventions

Gold Standard:
Index test:

Sponsors

Shenzhen children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Clinical diagnosis of non cardiac organ diffuse lesions or non contrast enhanced ultrasound examination showed non cardiac organs focal lesions; (2) in the past 1 months, dynamic CE-CT or CE-MRI tests have been carried out, or plans to carry out a dynamic CE-CT examination or histological biopsy within the month of the study, and may provide the original image (or copy) of the subjects; (3) subjects were 4 to 18 years old, to apply for non enhanced ultrasound or ultrasound guided renal biopsy of the hospital or outpatient; (4) the subjects have the ability and willingness to comply with the procedures, the subject and their legal guardians signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) there is a fatal disease in the patient (i.e., no more than 6 months); (2) subjects had previously received renal SonoVue angiography; (3) subjects had received or were receiving systemic or local chemotherapy or radiotherapy; (4) the participants were involved in another clinical trial using an unregistered drug, or less than 30 days after the completion of such clinical trials; (5) subjects with eggs or egg products allergy (body rash, shortness of breath, mouth or throat swelling, hypotension or shock symptoms); (6) known to be allergic to any ingredient of six fluoride or SonoVue; (7) the subjects in the examination within 24 hours before receiving contrast agent (such as iodinated X-ray contrast agent, magnetic resonance imaging contrast agents or other ultrasound contrast agent) examination; (8) the researchers believe that the subjects are not fit to participate in the study; (9) the subjects had a right to left shunt, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg) or uncontrolled systemic hypertension; (10) patients with coronary artery disease (Kawasaki), echocardiography, abnormal, or exercise drug test were abnormal; (11) subjects had recently suffered a heart disease, or other clinical instability factors (such as the recent ECG, laboratory or clinical symptoms of acute heart failure), III/IV heart failure or severe arrhythmia; (12) subjects had a history of respiratory distress syndrome, severe pulmonary emphysema, pulmonary vasculitis, or embolism.

Design outcomes

Primary

MeasureTime frame
Specific diagnosis;benign or malignant diagnosis;

Secondary

MeasureTime frame
Adverse drug reactions;

Countries

China

Contacts

Public ContactXIA BEI

Shenzhen Children's Hospital

xiabeimd@qq.com+86 18938690006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026