Normal Pediatric Liver and Spleen SWE

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-30

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This observational study aims to determine normal liver and spleen stiffness values in healthy children using shear wave elastography (SWE). The study will include participants from the pediatric age group without known liver or spleen disease. SWE measurements will be performed non-invasively to establish reference values. The results may contribute to improving diagnostic accuracy in pediatric elastography applications.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Shear Wave Sonoelastography in Pediatric Liver Fibrosis

NCT02372682

Sonoelastography Elastography Elastograms +4 more

COMPLETED

Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases

NCT01988753

Viral Hepatitis Liver Fibrosis Liver Disease +2 more

COMPLETED

Normal Liver Stiffness by MR Elastography

NCT03235414

Liver Diseases

COMPLETED NA

Quantitative Ultrasound to Assess Steatotic Liver Disease in Children

NCT06706856

MASLD MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

RECRUITING

Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy

NCT02041780

Liver Fibrosis Children

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Shear wave elastography (SWE) is a non-invasive imaging method used to assess tissue stiffness. While reference values for SWE have been established in adults, data regarding normal liver and spleen stiffness in children are limited. This single-center, cross-sectional observational study aims to establish normative SWE values for the liver and spleen in the pediatric age group. Children with no known liver or spleen pathology will undergo standardized SWE measurement under controlled conditions. Age-specific and sex-specific reference ranges will be analyzed, which may contribute to enhancing the clinical utility of SWE in pediatric practice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Stiffness Spleen Stiffness Shear Wave Elastography in Healthy Children Normal Organ Elasticity Pediatric Elastography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Children

This group includes healthy pediatric participants with no known liver or spleen disease. Each participant will undergo non-invasive shear wave elastography (SWE) to assess liver and spleen stiffness for the purpose of establishing normal reference values.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy children aged 0-18 years
* No known liver or spleen pathology
* Written informed consent obtained from parents or guardians

Exclusion Criteria

* Known liver disease (e.g., hepatitis, cirrhosis)
* Known spleen disease (e.g., splenomegaly)
* Any history of liver or spleen disease
* Age outside the 0-18 years range

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes