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OpenTrials
Completed

NCT Number: NCT06930066

Normal Pediatric Liver and Spleen SWE

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selçuk University Faculty of Medicine

Konya, 42130, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Normal liver and spleen stiffness values

    Time frame: Day 1

    This study aims to establish reference values for liver and spleen stiffness in healthy children using shear wave elastography (SWE).

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Normal Liver and Spleen Stiffness Values Using Shear Wave Elastography in Children

Acronym: SWE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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